Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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No Description
THE BINDING SITE GROUP LIMITED
NK623.T.A
In Commercial Distribution

  • 05051700016919 ()


  • Total immunoglobulin A (IgA total) IVD, kit, nephelometry/turbidimetry
No Description
HELENA LABORATORIES CORPORATION
552229
In Commercial Distribution

  • M5255522290 ()


  • Protein electrophoresis IVD, kit, electrophoresis
No Description
CHARMANT INC.
37-0085
In Commercial Distribution

  • 00883475954333 ()


  • Eyelid speculum, reusable
No Description
CHARMANT INC.
37-0064
In Commercial Distribution

  • 00883475952988 ()


  • Corneal marker, reusable
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4"(103mm),
Pajunk GmbH Medizintechnologie
021251-30A
Not in Commercial Distribution

  • 14048223024369 ()
  • 04048223024362 ()
021251-30A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4 3/4" (120mm), with Introducer,
Pajunk GmbH Medizintechnologie
041251-30A
Not in Commercial Distribution

  • 14048223024352 ()
  • 04048223024355 ()
041251-30A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 3 1/2" (90mm), sterile
Pajunk GmbH Medizintechnologie
001251-30A
Not in Commercial Distribution

  • 14048223024345 ()
  • 04048223024348 ()
001251-30A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 3 1/2" (90mm), with introducer
Pajunk GmbH Medizintechnologie
021251-29A
Not in Commercial Distribution

  • 14048223024307 ()
  • 04048223024300 ()
021251-29A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 3 1/2" (90mm), sterile
Pajunk GmbH Medizintechnologie
501251-29A
Not in Commercial Distribution

  • 14048223024260 ()
  • 04048223024263 ()
501251-29A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 123mm, with graduation, sterile
Pajunk GmbH Medizintechnologie
231251-27A
Not in Commercial Distribution

  • 14048223024239 ()
  • 04048223024232 ()
231251-27A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 4" (103mm) with Introducer,sterile
Pajunk GmbH Medizintechnologie
141251-27A
Not in Commercial Distribution

  • 14048223022815 ()
  • 04048223022818 ()
141251-27A

  • Spinal needle, single-use
SPROTTE® 2.G 25G x 123mm, with graduation, sterile
Pajunk GmbH Medizintechnologie
151251-29A
Not in Commercial Distribution

  • 14048223024574 ()
  • 04048223024577 ()
151251-29A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 3 1/2" (90mm),
Pajunk GmbH Medizintechnologie
121251-30A
Not in Commercial Distribution

  • 14048223024376 ()
  • 04048223024379 ()
121251-30A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 24G x 4 3/4" (120mm)
Pajunk GmbH Medizintechnologie
031251-30A
Not in Commercial Distribution

  • 14048223024321 ()
  • 04048223024324 ()
031251-30A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 4" (103mm),
Pajunk GmbH Medizintechnologie
041251-29A
Not in Commercial Distribution

  • 14048223024291 ()
  • 04048223024294 ()
041251-29A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 4 3/4" (120mm), with Introducer,
Pajunk GmbH Medizintechnologie
051251-29A
Not in Commercial Distribution

  • 14048223024284 ()
  • 04048223024287 ()
051251-29A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 6" (150mm), with Introducer,
Pajunk GmbH Medizintechnologie
061251-29A
Not in Commercial Distribution

  • 14048223024277 ()
  • 04048223024270 ()
061251-29A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 25G x 4 3/4" (120mm)
Pajunk GmbH Medizintechnologie
031251-29A
Not in Commercial Distribution

  • 14048223024253 ()
  • 04048223024256 ()
031251-29A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 4 3/4" (120mm) with introducer,
Pajunk GmbH Medizintechnologie
151251-27A
Not in Commercial Distribution

  • 14048223022822 ()
  • 04048223022825 ()
151251-27A

  • Spinal needle, single-use
SPROTTE® 2.G Standard Sprotte Needle 2nd generation 27G x 3 1/2" (90mm) with Introducer
Pajunk GmbH Medizintechnologie
121251-27A
Not in Commercial Distribution

  • 14048223022808 ()
  • 04048223022801 ()
121251-27A

  • Spinal needle, single-use
Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.2-2-20-GT-17-20
In Commercial Distribution

  • 00853730006121 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable
Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.2-2-10-GT-17-20
In Commercial Distribution

  • 00853730006114 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable
Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.0-2-20-GT-18-20
In Commercial Distribution

  • 00853730006107 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable
Implanted Marker in Needle
CORTEX MANUFACTURING INC.
FM-1.0-2-10-GT-18-20
In Commercial Distribution

  • 00853730006091 ()


  • Brachytherapy injection needle
  • Radiological image marker, implantable
No Description
Lonza Verviers
BE15-605X0.200
In Commercial Distribution

  • 05407010125948 ()
BE15-605X0.200

  • Ex vivo cell culture medium
RBN-116S P/N 74093-02M
RANFAC CORP.
11GA X 6"
In Commercial Distribution

  • 20857878007679 ()
  • 10857878007672 ()
  • 00857878007675 ()

  • Needle Gauge: 11 Gauge
  • Length: 6 Inch
RBN-116S

  • Bone marrow biopsy needle, single-use
BAN-11SF, F/G, Sterile P/N: 74322-01M
RANFAC CORP.
11 Gauge x 13cm
In Commercial Distribution

  • 20857878007440 ()
  • 10857878007443 ()
  • 00857878007446 ()

  • Length: 13 Centimeter
  • Needle Gauge: 11 Gauge
BAN-11SF

  • Bone access cannula
MC-RAN-8C, STERILE F/G MARROW CELLUTIONS ASPIRATION NEEDLE PN 74304-01M 11GA X 9CM ASPIRATION NEEDLE WITH ADDITIONAL 8GA X 10CM BIOPSY NEEDLE
RANFAC CORP.
11 Gauge X 9CM
In Commercial Distribution

  • 20857878007204 ()
  • 10857878007207 ()
  • 00857878007200 ()

  • Needle Gauge: 8 Gauge
  • Length: 10 Centimeter
  • Needle Gauge: 11 Gauge
  • Length: 9 Centimeter
MC-RAN-8C

  • Bone access cannula
MC-RAN-11C, STERILE F/G PN 74303-01M MARROW CELLUTIONS ASPIRATION NEEDLE, DOUBLE POUCHED
RANFAC CORP.
11 Gauge x 9CM
In Commercial Distribution

  • 20857878007198 ()
  • 10857878007191 ()
  • 00857878007194 ()

  • Needle Gauge: 11 Gauge
  • Length: 9 Centimeter
MC-RAN-11C

  • Bone access cannula
RAN-86-14, PN# 74099-01M
RANFAC CORP.
8GA x 6"
In Commercial Distribution

  • 00857878007057 ()
  • 10857878007054 ()
  • 20857878007051 ()

  • Needle Gauge: 8 Gauge
  • Length: 6 Inch
RAN-86-14

  • Bone access cannula
RAN-16(2.8)N5T, F/G PN 74048-03M
RANFAC CORP.
16GA x 2.8"
In Commercial Distribution

  • 20858690006895 ()
  • 10858690006898 ()
  • 00858690006891 ()

  • Length: 2.8 Inch
  • Needle Gauge: 16 Gauge
RAN-16(2.8)N5T

  • Bone access cannula
RBN-116, F/G, STERILE P/N 74049-02M
RANFAC CORP.
11 Gauge X 6"
In Commercial Distribution

  • 10858690006386 ()
  • 00858690006389 ()
  • 20858690006383 ()

  • Length: 6 Inch
  • Needle Gauge: 11 Gauge
RBN-116

  • Bone marrow biopsy needle, single-use
RBN-86 P/N 74225-01M
RANFAC CORP.
8GA X 6"
In Commercial Distribution

  • 00858690006365 ()
  • 10858690006362 ()
  • 20858690006369 ()

  • Length: 6 Inch
  • Needle Gauge: 8 Gauge
RBN-86

  • Bone marrow biopsy needle, single-use
MC-RAN-8C, STERILE F/G MARROW CELLUTIONS ASPIRATION NEEDLE PN 74266-01M 11GA X 9CM ASPIRATION NEEDLE WITH ADDITIONAL 8GA X 10CM BIOPSY NEEDLE CE REMOVED ON 05.17.18
RANFAC CORP.
11 Gauge X 9CM
In Commercial Distribution

  • 20858690006284 ()
  • 10858690006287 ()
  • 00858690006280 ()

  • Needle Gauge: 8 Gauge
  • Length: 10 Centimeter
  • Length: 9 Centimeter
  • Needle Gauge: 11 Gauge
MC-RAN-8C

  • Bone access cannula
MC-RAN-11CSTS, STERILE F/G MARROW CELLUTIONS ASPIRATION NEEDLE PN 74219-07M
RANFAC CORP.
11 Gauge X 11CM
In Commercial Distribution

  • 20858690006086 ()
  • 10858690006089 ()
  • 00858690006082 ()

  • Needle Gauge: 11 Gauge
  • Length: 11 Centimeter
MC-RAN-11CSTS

  • Bone access cannula
MC-RAN-11C, STERILE F/G PN 74219-06M MARROW CELLUTIONS ASPIRATION NEEDLE
RANFAC CORP.
11 Gauge x 9CM
In Commercial Distribution

  • 20858690006079 ()
  • 10858690006072 ()
  • 00858690006075 ()

  • Needle Gauge: 11 Gauge
  • Length: 9 Centimeter
MC-RAN-11C

  • Bone access cannula
MC-RAN-11CSTS, STERILE F/G MARROW CELLUTIONS ASPIRATION NEEDLE PN 74279-02M
RANFAC CORP.
11 Gauge X 11CM
In Commercial Distribution

  • 20858690006017 ()
  • 10858690006010 ()
  • 00858690006013 ()

  • Length: 11 Centimeter
  • Needle Gauge: 11 Gauge
74279-02M

  • Bone access cannula
MC-RAN-11C, STERILE F/G PN 74279-01M MARROW CELLUTIONS ASPIRATION NEEDLE
RANFAC CORP.
11 Gauge x 9CM
In Commercial Distribution

  • 20858690006000 ()
  • 10858690006003 ()
  • 00858690006006 ()

  • Length: 9 Centimeter
  • Needle Gauge: 11 Gauge
74279-01M

  • Bone access cannula
Orange G Staining Solution for Papanicolau Staining
TRANSENE COMPANY, INC.
1
In Commercial Distribution

  • M8003852042008 ()

  • Total Volume: 1 Gallon
  • Total Volume: 1 Quart
  • Total Volume: 1 Pint
  • Total Volume: 8 Fluid Ounce
  • Total Volume: 4 Fluid Ounce
M-800-3

  • Biological stain IVD
COPAL® G+V is a standard-setting, high-viscosity, radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement and designed for fixation of COPAL® exchange G hip spacer to the host bone. It contains the aminoglycoside antibiotic gentamicin and the glycopeptide antibiotic vancomycin to protect the cured bone cement and surrounding tissue from colonization by bacteria that are sensitive to gentamicin and/or vancomycin. It contains the X-ray contrast medium zirconium dioxide. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex(E141). The bone cement consists of two components and is prepared immediately before use by mixing the polymer powder with the monomer liquid. COPAL® G+V is intended for single-use and is supplied sterile.
Heraeus Medical GmbH
1x40
In Commercial Distribution

  • 04260102139862 ()
  • 04260102139855 ()
  • 04260102139879 ()
5184267

  • Orthopaedic cement, antimicrobial
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip M medium
In Commercial Distribution

  • 04260102139220 ()
  • 04260102139206 ()
  • 04260102139213 ()
5147216

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip S medium
In Commercial Distribution

  • 04260102139190 ()
  • 04260102139176 ()
  • 04260102139183 ()
5147215

  • Orthopaedic cement spacer
The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
Heraeus Medical GmbH
knee L
In Commercial Distribution

  • 04260102136991 ()
  • 04260102136977 ()
  • 04260102136984 ()
5034796

  • Orthopaedic cement spacer
The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
Heraeus Medical GmbH
knee M
In Commercial Distribution

  • 04260102136960 ()
  • 04260102136946 ()
  • 04260102136953 ()
5034797

  • Orthopaedic cement spacer
The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.
Heraeus Medical GmbH
knee S
In Commercial Distribution

  • 04260102136939 ()
  • 04260102136915 ()
  • 04260102136922 ()
5034798

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip XL short
In Commercial Distribution

  • 04260102136885 ()
  • 04260102136908 ()
  • 04260102136892 ()
5034795

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip L short
In Commercial Distribution

  • 04260102136878 ()
  • 04260102136854 ()
  • 04260102136861 ()
5034788

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip M short
In Commercial Distribution

  • 04260102136847 ()
  • 04260102136823 ()
  • 04260102136830 ()
5034791

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip S short
In Commercial Distribution

  • 04260102136816 ()
  • 04260102136793 ()
  • 04260102136809 ()
5034793

  • Orthopaedic cement spacer
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
Heraeus Medical GmbH
hip XL long
In Commercial Distribution

  • 04260102136786 ()
  • 04260102136762 ()
  • 04260102136779 ()
5034794

  • Orthopaedic cement spacer
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