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
Zimmer GmbH
01.00102.625
In Commercial Distribution

  • 00889024593541 ()

  • 25 265mm
01.00102.625

  • Revision uncoated hip femur prosthesis
No Description
Zimmer, Inc.
SSI008203
In Commercial Distribution

  • 00889024693937 ()

  • Sz 2-5
SSI008203

  • Surgical drill guide, reusable
No Description
Zimmer GmbH
01.00103.025
In Commercial Distribution

  • 00889024480650 ()

  • 25 305mm
01.00103.025

  • Revision uncoated hip femur prosthesis
Syphilis Screening Test, Export
ARLINGTON SCIENTIFIC, INC.
NC-900025E
In Commercial Distribution

  • 00816057020706 ()

  • 25 Test
NC-900025E

  • Treponema pallidum reagin antibody IVD, kit, agglutination
Syphilis Screening Test
ARLINGTON SCIENTIFIC, INC.
NC-900025
In Commercial Distribution

  • 00816057020690 ()

  • 25 Test
NC-900025

  • Treponema pallidum reagin antibody IVD, kit, agglutination
Detection of Rheumatoid Factor
ARLINGTON SCIENTIFIC, INC.
NC-700025DC-E
In Commercial Distribution

  • 00816057020478 ()

  • 25 Tests
NC-700025DC-E

  • Rheumatoid factor IVD, kit, agglutination
Detection of Rheumatoid Factor
ARLINGTON SCIENTIFIC, INC.
NC-700025DC
In Commercial Distribution

  • 00816057020461 ()

  • 25 Tests
NC-700025DC

  • Rheumatoid factor IVD, kit, agglutination
Detection of C-Reactive Protein, Export
ARLINGTON SCIENTIFIC, INC.
NC-500025E
In Commercial Distribution

  • 00816057020348 ()

  • 25 Tst
NC-500025E

  • C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
Detection of C-Reactive Protein
ARLINGTON SCIENTIFIC, INC.
NC-500025
In Commercial Distribution

  • 00816057020331 ()

  • 25 Test
NC-500025

  • C-reactive protein (CRP) IVD, kit, precipitation/immunodiffusion
Detection of heterophil antibodies associated with infectious mononucleosis, Export
ARLINGTON SCIENTIFIC, INC.
NC-450025E
In Commercial Distribution

  • 00816057020270 ()

  • 25 Test
NC-450025E

  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Detection of heterophil antibodies associated with infectious mononucleosis
ARLINGTON SCIENTIFIC, INC.
NC-450025
In Commercial Distribution

  • 00816057020263 ()

  • 25 Test
NC-450025

  • Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination
Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
ARLINGTON SCIENTIFIC, INC.
NC-350025E
In Commercial Distribution

  • 00816057020201 ()

  • 25 Test
NC-350025E

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent
Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
ARLINGTON SCIENTIFIC, INC.
NC-350025
In Commercial Distribution

  • 00816057020195 ()

  • 25 Test
NC-350025

  • Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent
Detection of Anti-Strptolysin-O, Export
ARLINGTON SCIENTIFIC, INC.
NC-300025E
In Commercial Distribution

  • 00816057020133 ()

  • 25 Test
NC-300025E

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Detection of Anti-Streptolysin O
ARLINGTON SCIENTIFIC, INC.
NC-300025
In Commercial Distribution

  • 00816057020126 ()

  • 25 Test
NC-300025

  • Beta-haemolytic Group A Streptococcus streptolysin O antibody IVD, reagent
Detection of coagulase associated with Staph. aureus, Export
ARLINGTON SCIENTIFIC, INC.
NC-280-2-25CE
In Commercial Distribution

  • 00816057020072 ()

  • 25 Test
NC-280-2-25CE

  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Detection of coagulase associated with Staph aureus
ARLINGTON SCIENTIFIC, INC.
NC-280-2-25C
In Commercial Distribution

  • 00816057020065 ()

  • 25 Test
NC-280-2-25C

  • Staphylococcus aureus culture isolate antigen IVD, kit, agglutination
Detection of the presence of Hgb-S for Export
ARLINGTON SCIENTIFIC, INC.
NC-200025E
In Commercial Distribution

  • 00816057020010 ()

  • 25 Test
NC-200025E

  • Haemoglobin S (HbS) IVD, reagent
Detection of presence of Hgb-S
ARLINGTON SCIENTIFIC, INC.
NC-200025
In Commercial Distribution

  • 00816057020003 ()

  • 25 Test
NC-200025

  • Haemoglobin S (HbS) IVD, reagent
No Description
Zimmer, Inc.
00-5977-056-03
In Commercial Distribution

  • 00889024216525 ()

  • 25 mm
00-5977-056-03

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
00-5450-013-46
In Commercial Distribution

  • 00889024308299 ()

  • 25 mm
00-5450-013-46

  • Knee arthroplasty wedge
SEVERIN LACRIMAL CANNULA CURVED TIP
SONTEC INSTRUMENTS, INC.
1103-500F
In Commercial Distribution

  • 00192896053182 ()

  • 25 Gauge
1103-500F

  • Ophthalmic working-channel cannula, reusable
ACUMATCH L-SERIES SZ 2-5 COLLARED NECK TRIAL
Exactech, Inc.
113-05-40
In Commercial Distribution

  • 10885862017055 ()

  • SIZE 2-5
113-05-40

  • Femoral stem prosthesis trial
ACUMATCH COLLARED SZ 2-5 C&P SERIES NECK TRIAL
Exactech, Inc.
113-03-40
In Commercial Distribution

  • 10885862016911 ()

  • SIZE 2-5
113-03-40

  • Femoral stem prosthesis trial
AURA NECK TRIAL SZ 2-5
Exactech, Inc.
107-03-40
In Commercial Distribution

  • 10885862015235 ()

  • SIZE 2-5
107-03-40

  • Femoral stem prosthesis trial
No Description
BIOMET MICROFIXATION, INC
02-2025
In Commercial Distribution

  • 00841036021009 ()

  • 25 grams


  • Orthopaedic cement, non-antimicrobial
No Description
Exactech, Inc.
308-15-25
In Commercial Distribution

  • 10885862268228 ()

  • Size 25
308-15-25

  • Humeral stem extension prosthesis
The Titan Reverse Shoulder baseplate is a glenoid component secured by four peripheral screws, two of which can be locked, as well as a central larger compression screw. The baseplate is partially coated with asymmetrical sintered beads for secondary fixation.
Ascension Orthopedics, Inc.
GBP096003025
In Commercial Distribution

  • 10381780121695 ()
  • M268GBP0960030251 ()

  • 25 mm
GBP-0960-030-25

  • Reverse shoulder prosthesis base plate
PECTUS BAR, ANGLED, CP TITANIUM
KLS-Martin L.P.
24-071-25-09
In Commercial Distribution

  • 00888118135742 ()

  • 25 CM


  • Orthopaedic fixation plate, non-bioabsorbable
PECTUS BAR, CP TITANIUM
KLS-Martin L.P.
24-070-25-09
In Commercial Distribution

  • 00888118135551 ()

  • 25 CM


  • Orthopaedic fixation plate, non-bioabsorbable
KIM, W/SCOPE CLAMP HOLDER, 6 MM BLADE
KLS-Martin L.P.
38-518-25-07
In Commercial Distribution

  • 00888118128539 ()

  • 25 CM


  • Hand-held dental retractor
KIM, W/SCOPE CLAMP HOLDER, 6 MM BLADE
KLS-Martin L.P.
99-592-06-01
In Commercial Distribution

  • 00888118119780 ()

  • 25 CM


  • Hand-held dental retractor
FORCEPS, HOLDING, PLATE, RIB, PRESS, ROTATING
KLS-Martin L.P.
24-015-72-07
In Commercial Distribution

  • 00888118116666 ()

  • 25 CM


  • Surgical implant/trial-implant/sizer holder, reusable
BONE, LEXER, CURVED, 10 MM TIP
KLS-Martin L.P.
23-131-60-07
In Commercial Distribution

  • 00888118115409 ()

  • 25 CM


  • Surgical gouge
RAMUS, RIGHT, 4 MM TIP
KLS-Martin L.P.
37-544-06-07
In Commercial Distribution

  • 00888118107626 ()

  • 25 CM


  • ENT elevator
RAMUS, LEFT, 4 MM TIP
KLS-Martin L.P.
37-544-05-07
In Commercial Distribution

  • 00888118107619 ()

  • 25 CM


  • ENT elevator
RAMUS, RIGHT, 6 MM TIP
KLS-Martin L.P.
37-544-04-07
In Commercial Distribution

  • 00888118107602 ()

  • 25 CM


  • ENT elevator
RAMUS, LEFT, 6 MM TIP
KLS-Martin L.P.
37-544-03-07
In Commercial Distribution

  • 00888118107596 ()

  • 25 CM


  • ENT elevator
RAMUS, RIGHT, W/PIN
KLS-Martin L.P.
15-318-02-07
In Commercial Distribution

  • 00888118107367 ()

  • 25 CM


  • Hand-held surgical retractor, reusable
RAMUS, LEFT, W/PIN
KLS-Martin L.P.
15-318-01-07
In Commercial Distribution

  • 00888118107350 ()

  • 25 CM


  • Hand-held surgical retractor, reusable
BENDING, BONE, WOO
KLS-Martin L.P.
99-594-91-01
In Commercial Distribution

  • 00888118124067 ()

  • 25 CM


  • Bone holding forceps
DIST, LEFORT 3/MONO, MESH MIDFACE, END DRV, LEFT, BODY ONLY, 1.5-1.8 MM SCREW, TI-6AL-4V
KLS-Martin L.P.
99-490-78-02
In Commercial Distribution

  • 00888118106346 ()

  • 25 MM


  • Implantable craniofacial bone distractor
ACT ARM, RIGID, CARDANIC, TI-6AL-4V
KLS-Martin L.P.
51-401-25-71
In Commercial Distribution

  • 00888118104403 ()

  • 25 MM


  • Implantable craniofacial bone distractor
N-Tralig® Intraligamentary Syringe Cartridge Barrel, Shield Window
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
PN3SS
In Commercial Distribution

  • 10381780174875 ()

  • Outer Diameter: 12 Millimeter
  • 2-5/8"
PN3SS

  • Dental anaesthesia syringe, reusable
N-Tralig® Intraligamentary Syringe Cartridge Barrel, Solid Wall
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
PN2SS
In Commercial Distribution

  • 10381780174868 ()

  • 2-5/8"
  • Outer Diameter: 11 Millimeter
PN2SS

  • Dental anaesthesia syringe, reusable
No Description
Biomet Orthopedics, LLC
105425
In Commercial Distribution

  • 00887868230035 ()

  • 25 SIZE
105425

  • Acetabular shell
No Description
Biomet Orthopedics, LLC
SSI004319
In Commercial Distribution

  • 00887868241208 ()

  • Size 25
SSI004319

  • Patella prosthesis trial
ADSON, BLUNT, 3 X 4 TEETH, 26 MM BLADE
KLS-Martin L.P.
15-771-26-07
In Commercial Distribution

  • 00888118022288 ()

  • 25 CM


  • Self-retaining surgical retractor, reusable
No Description
KLS-Martin L.P.
14-360-25-07
Not in Commercial Distribution

  • 00888118020161 ()

  • 25 CM


  • Dressing/utility forceps, scissors-like, reusable
SPONGE, FOERSTER, CURVED, SMOOTH
KLS-Martin L.P.
14-353-25-07
In Commercial Distribution

  • 00888118020123 ()

  • 25 CM


  • Dressing/utility forceps, scissors-like, reusable
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