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, Inc.
42-5891-007-30
In Commercial Distribution

  • 00889024557826 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / E, F
42-5891-007-30

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5891-005-30
In Commercial Distribution

  • 00889024557802 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / C, D
42-5891-005-30

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5892-009-20
In Commercial Distribution

  • 00889024557734 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / G, H
42-5892-009-20

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5892-007-20
In Commercial Distribution

  • 00889024557710 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / E, F
42-5892-007-20

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5892-005-20
In Commercial Distribution

  • 00889024557697 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / C, D
42-5892-005-20

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5891-009-20
In Commercial Distribution

  • 00889024560499 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / G, H
42-5891-009-20

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5891-007-20
In Commercial Distribution

  • 00889024560475 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / E, F
42-5891-007-20

  • Knee tibia prosthesis trial, reusable
No Description
Zimmer, Inc.
42-5891-005-20
In Commercial Distribution

  • 00889024560451 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / C, D
42-5891-005-20

  • Knee tibia prosthesis trial, reusable
9" X 9" NON-STERILE BULK PACKED, POLYESTER LASER SEALED EDGE 140 GRAM WIPERS - 100 wipers PER BAG
CYGNUS MEDICAL L.L.C.
PW0909100
In Commercial Distribution

  • 10843356102489 ()
  • 00843356102482 ()
  • 30843356102483 ()


  • Medical device cleaning/disinfection wipe
LINT FREE ABSORBENT WIPERS 140 GRAMS 9" X 9" POLYESTER WIPERS PER POUCH- 2 Wipers per Pouch
CYGNUS MEDICAL L.L.C.
WN0909-2
In Commercial Distribution

  • 10843356102465 ()
  • 00843356102468 ()
  • 30843356102469 ()


  • Medical device cleaning/disinfection wipe
cobb-type spinal elevator, solid hexagonal handle, 9 1/2" (24.0 cm), 3/8" (9 .0 mm) blade
NOVO SURGICAL, INC.
N3761-12
In Commercial Distribution

  • 00842331137617 ()
N3761-12

  • Bone lever/elevator, reusable
Teardrop Suction Tube Non-Tapered, 9 fr, TL180mm WL 140mm(5 1/2"), OL 236mm(9 1/4")
Avalign Technologies, Inc.
VM85-6640
In Commercial Distribution

  • 00190776157586 ()


  • Surgical/emergency suction cannula, non-illuminating, reusable
KERN-LANE Bone Holding Forceps, 9 1/2", (240 mm), with ratchet fixation, width: 9 mm, non-sterile, reusable
Aesculap AG
FO158R
In Commercial Distribution

  • 04038653047413 ()
FO158R

  • Bone holding forceps
V. Mueller RHOTON LOOP CURETTE BLUNT, MALLEABLE LOOP 9 X 5MM WIDE OVERALL LENGTH 9 inches 22.7CM
STERIS CORPORATION
NL3785-146
In Commercial Distribution

  • 10885403074714 ()
NL3785146

  • Neurosurgical curette, single-use
GRIFFITHS-BROWN Tissue Forceps, delicate, 1.5mm x 5mm BROWN-type teeth, 9×9 teeth, Castro-type handle, 4 3/4"
BR Surgical, LLC
BR10-18813
In Commercial Distribution

  • 00840183519070 ()
BR10-18813

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Resano Brown Forceps Double Action 2.5 Millimeters Tip 9 x 9 Teeth Round Handle Counter Weight Titanium
SONTEC INSTRUMENTS, INC.
2601-306
In Commercial Distribution

  • 00192896121195 ()

  • Length: 12 Inch
2601-306

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
Resano Brown Forceps Double Action 2.5 Millimeters Tip 9 x 9 Teeth Round Handle Counter Weight Titanium
SONTEC INSTRUMENTS, INC.
2601-304
In Commercial Distribution

  • 00192896121188 ()

  • Length: 10 Inch
2601-304

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable
ChitoPulse™ is a compression device incorporating a hemostatic chitosan patch that, when positioned directly onto an access site, applies localized mechanical pressure to promote hemostasis and rapid control of bleeding. The chitosan patch acts as an adjunct to the mechanical compression provided by the adjustable strap and compression balloon to aid the control of bleeding. Using the inflation syringe, the compression applied by the device can be controlled by the user without unfastening the band, allowing gradual release of compression as hemostasis occurs. ChitoPulse™ is a single use device. Once hemostasis is achieved, the adjustable band is intended to be removed leaving the hemostatic chitosan patch in place. The hemostatic chitosan patch can be secured in place with a securement dressing and left in situ for up to 24 hrs. ChitoPulse™ also provides a barrier against bacterial penetration by a wide range of gram positive and gram negative organisms.
TRICOL BIOMEDICAL, INC.
1
In Commercial Distribution

  • 00870053000063 ()
  • 20870053000067 ()
  • 50870053000068 ()
1095

  • Radial artery compression device
Rabbit antiserum, Ready to use
Ssi Diagnostica A/S
16903
In Commercial Distribution

  • 05713106169032 ()
16903

  • Streptococcus pneumoniae culture isolate antigen IVD, antibody
No Description
Lonza Verviers
BESP845K
In Commercial Distribution

  • 05407010126600 ()
BESP845K

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP845J
In Commercial Distribution

  • 05407010126501 ()
BESP845J

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP845B
In Commercial Distribution

  • 05407010126495 ()
BESP845B

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP845B1
In Commercial Distribution

  • 05407010127003 ()
BESP845B1

  • Ex vivo cell culture medium
No Description
Lonza Verviers
BESP845L
In Commercial Distribution

  • 05407010126617 ()
BESP845L

  • Ex vivo cell culture medium
Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
In Commercial Distribution

  • 00310866002422 ()
07810

  • Gingival retraction cord, medicated
Twisted Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07810
Not in Commercial Distribution

  • 00310866000589 ()
07810

  • Gingival retraction cord, medicated
Untreated Braided Gingival Retraction Cord, 100 inches, Size: 9/1
PASCAL COMPANY, INC.
07410
In Commercial Distribution

  • 00310866000466 ()
07410

  • Gingival retraction cord, non-medicated
Braided Gingival Retraction Cord with Epinephrine and Zinc Phenolsulfonate, 72 inches, Size:9/1,
PASCAL COMPANY, INC.
07310
In Commercial Distribution

  • 00310866000428 ()
07310

  • Gingival retraction cord, medicated
Braided gingival retraction cord with epinephrine, 72 inches, size 9/1
PASCAL COMPANY, INC.
07210
In Commercial Distribution

  • 00310866000381 ()
07210

  • Gingival retraction cord, medicated
Braided Gingival Retraction Cord with Aluminum Sulfate, 72 inches, Size: 9/1
PASCAL COMPANY, INC.
07110
In Commercial Distribution

  • 00310866000343 ()
07110

  • Gingival retraction cord, non-medicated
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
591-009
In Commercial Distribution

  • 09348215137793 ()


  • Orthopaedic broach
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
59-0109
In Commercial Distribution

  • 09348215137663 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
59-0009
In Commercial Distribution

  • 09348215137533 ()


  • Coated hip femur prosthesis, modular
No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-20-6909
In Commercial Distribution

  • 09348215073435 ()


  • Orthopaedic broach
No Description
W.H. Holden, Inc.
10-6105
In Commercial Distribution

  • D9281061050 ()


  • Dental suction system cannula, reusable
No Description
W.H. Holden, Inc.
10-6102
In Commercial Distribution

  • D9281061020 ()


  • Dental suction system cannula, reusable
No Description
Dynarex Corporation
4621
In Commercial Distribution

  • 00616784462134 ()
  • 00616784462110 ()


  • Tracheostomy tube neck holder, reusable
Siemens Healthcare Diagnostics Reagent Strips for Urinalysis include test pads for protein, blood, leukocytes, nitrite, glucose, ketone (aceto-acetic acid), pH, specific gravity and bilirubin
Siemens Healthcare Diagnostics Inc.
10337216
In Commercial Distribution

  • 00630414549026 ()
  • 00630414009681 ()
A2163B16

  • Multiple urine analyte IVD, kit, rapid colorimetric, clinical
No Description
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
0441
In Commercial Distribution

  • 00848665001877 ()


  • Surgical screwdriver, reusable
No Description
MedXpert GmbH
014-01009
In Commercial Distribution

  • 04260029580921 ()
014-01009

  • Rib/rib cage internal fixation/bracing system fixation grip/anchor
Syva® RapidTest d.a.u.® 9 mAMP / OPI / COC / THC / PCP / BZO / BAR / TCA / AMP
Siemens Healthcare Diagnostics Inc.
10445362
Not in Commercial Distribution

  • 00842768001338 ()
  • 00630414013961 ()
6A279UL

  • Multiple drugs of abuse IVD, kit, rapid ICT, clinical
No Description
DRAEGER MEDICAL SYSTEMS, INC.
5947804
In Commercial Distribution

  • 04049098008013 ()
  • 04049098058223 ()


  • Electrocardiographic lead set, reusable
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-6401-9 G
In Commercial Distribution

  • 04049016124917 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
No Description
EUROIMMUN Medizinische Labordiagnostika AG
DL 1590-1601-9 G
In Commercial Distribution

  • 04049016124900 ()


  • Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)
No Description
W.H. Holden, Inc.
10-5199-9SECH
In Commercial Distribution

  • D9281051999SECH0 ()


  • Dental osteotome set
No Description
W.H. Holden, Inc.
10-5199-9HD
In Commercial Distribution

  • D9281051999HD0 ()


  • Dental osteotome set
No Description
W.H. Holden, Inc.
10-5199-9CH
In Commercial Distribution

  • D9281051999CH0 ()


  • Dental osteotome set
No Description
W.H. Holden, Inc.
10-5109NAPAV
In Commercial Distribution

  • D928105109NAPAV0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5109HF
In Commercial Distribution

  • D928105109HF0 ()


  • Bone curette, reusable
No Description
W.H. Holden, Inc.
10-5109HD
In Commercial Distribution

  • D928105109HD0 ()


  • Bone curette, reusable
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