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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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ORIO - 00193082001758

ORIO-PL PEEK PLIF Cage 9mm wide, 8 deg. Lordosis, 9 X 9 X 24mm
SPINECRAFT, LLC
L7409-09-824
In Commercial Distribution

  • 00193082001758 ()
L7409-09-824

  • Polymeric spinal interbody fusion cage

ORIO - 00193082001741

ORIO-PL PEEK PLIF Cage 9mm wide, 8 deg. Lordosis, 9 X 9 X 22mm
SPINECRAFT, LLC
L7409-09-822
In Commercial Distribution

  • 00193082001741 ()
L7409-09-822

  • Polymeric spinal interbody fusion cage

ORIO - 00193082001529

ORIO-PL PEEK PLIF Cage 9mm wide, 5 deg. Lordosis, 9 X 9 X 26mm
SPINECRAFT, LLC
L7109-09-526
In Commercial Distribution

  • 00193082001529 ()
L7109-09-526

  • Polymeric spinal interbody fusion cage

ORIO - 00193082001512

ORIO-PL PEEK PLIF Cage 9mm wide, 5 deg. Lordosis, 9 X 9 X 24mm
SPINECRAFT, LLC
L7109-09-524
In Commercial Distribution

  • 00193082001512 ()
L7109-09-524

  • Polymeric spinal interbody fusion cage

ORIO - 00193082001505

ORIO-PL PEEK PLIF Cage 9mm wide, 5 deg. Lordosis, 9 X 9 X 22mm
SPINECRAFT, LLC
L7109-09-522
In Commercial Distribution

  • 00193082001505 ()
L7109-09-522

  • Polymeric spinal interbody fusion cage

Sterile Lint Free Absorbent Wipers - 00843356102451

Sterile Lint Free Absorbent Wipers 9" X 9" Polyester Wipers - 2 Wipers per Pouch
CYGNUS MEDICAL L.L.C.
ST0909
In Commercial Distribution

  • 00843356102451 ()
  • 30843356102452 ()
  • 10843356102458 ()
  • 20843356102455 ()


  • Medical device cleaning/disinfection wipe

BOSS Instruments - 00888515206755

Boss Steinman Pin Smooth, 9", single diamond, rnd end, 9/64" 6 PER PACK
BOSS INSTRUMENTS, LTD., INC.
79-1122
In Commercial Distribution

  • 00888515206755 ()
79-1122

  • Orthopaedic trocar blade, reusable

Integra® Jarit® - 10381780180708

Integra® Jarit® Brown-Adson Tissue Forceps, 4-7/8", Angled, 9 x 9 Teeth
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
130270
In Commercial Distribution

  • M2741302701 ()
  • 10381780180708 ()
130-270

  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Dupress® - 00809958092620

9 in X 9 in, 8-ply Burn dressing. Bundled and packaged in 10s. Sterile.
Derma Sciences Canada Inc
9825
In Commercial Distribution

  • 00809958092620 ()
  • 00809958092606 ()

  • 9 in X 9 in
  • 23 cm X 23 cm
DUP9825

  • Non-woven gauze pad

Quartet™ - 05414734503198

Left Heart Lead
ST. JUDE MEDICAL, INC.
1458Q-86
In Commercial Distribution

  • 05414734503198 ()

  • Length: 86 Centimeter
1458Q-86

  • Endocardial/interventricular septal pacing lead

KENEX - 05055449411516

312/DS-039/9 Table Shield 162cm Wide With Two Din Rails
KENEX (ELECTRO-MEDICAL) LIMITED
312/DS-039/9
In Commercial Distribution

  • 05055449411516 ()
312/DS-039/9

  • Radiation shielding curtain

DRYASOL - B467ACP4522575100

Dryasol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
45225-75100
In Commercial Distribution

  • B467ACP452257510016 ()
  • B467ACP4522575100 ()
  • B467ACP452257510020 ()
  • B467ACP452257510025 ()
ACP8/9/10

  • Haemodialysis concentrate

Z-Max - D768CSZMAX7890

Cover Screw
KEYSTONE DENTAL, INC.
CS-Z-MAX-7/8/9
Not in Commercial Distribution

  • D768CSZMAX7890 ()

  • Outer Diameter 7.0 -9.0mm
CS-Z-MAX-7/8/9

  • Dental implant suprastructure, temporary, preformed, single-use

DELTA-9-THC 8 NG/ML - B800DELTA9THC8NGML0

DELTA-9-THC 8 NG/ML
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9THC8NGML5 ()
  • B800DELTA9THC8NGML0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control

DELTA-9-THC 8 NG/ML - B800DELTA9OMEGA0

No Description
UTAK LABORATORIES, INC.
DELTA 9 OMEGA
In Commercial Distribution

  • B800DELTA9OMEGA5 ()
  • B800DELTA9OMEGA0 ()

  • Total Volume: 1 Milliliter
DELTA 9 OMEGA

  • Multiple-type clinical chemistry analyte profile IVD, control

Nasal Implant - B049SN9W0

Sterile, silicone, nasal implant.
Hanson Medical, Inc.
SN - 9 W
In Commercial Distribution

  • B049SN9W0 ()
SN - 9 W

  • Nasal cartilage support implant, non-bioabsorbable

Nasal Implant - B049SN9F0

Sterile, silicone, nasal implant.
Hanson Medical, Inc.
SN - 9 F
In Commercial Distribution

  • B049SN9F0 ()
SN - 9 F

  • Nasal cartilage support implant, non-bioabsorbable

Nasal Implant - B049N9W0

Non-sterile, silicone, nasal implant.
Hanson Medical, Inc.
N - 9 W
In Commercial Distribution

  • B049N9W0 ()
N - 9 W

  • Nasal cartilage support implant, non-bioabsorbable

Nasal Implant - B049N9S0

Non-sterile, silicone, nasal implant, sizer.
Hanson Medical, Inc.
N - 9 S
In Commercial Distribution

  • B049N9S0 ()
N - 9 S

  • Nasal cartilage support implant, non-bioabsorbable

Nasal Implant - B049N9F0

Non-sterile, silicone, nasal implant.
Hanson Medical, Inc.
N - 9 F
In Commercial Distribution

  • B049N9F0 ()
N - 9 F

  • Nasal cartilage support implant, non-bioabsorbable

Aaris Acrylic Intraocular lens(IOL) - 00884872025732

No Description
Aaren Scientific Inc.
EC-3 PAL
In Commercial Distribution

  • 00884872025732 ()
fEC-3 PAL/9

  • Posterior-chamber intraocular lens, pseudophakic

NA - ENTTCAM9S3D50601

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D5.060
In Commercial Distribution

  • ENTTCAM9S3D50601 ()

  • CAM-Series 5,0 mm
CAM 9.S3D5.060

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTCAM9S3D43001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D4.300
In Commercial Distribution

  • ENTTCAM9S3D43001 ()

  • CAM-Series 4,3 mm
CAM 9.S3D4.300

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTCAM9S3D38001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D3.800
In Commercial Distribution

  • ENTTCAM9S3D38001 ()

  • CAM-Series 3,8 mm
CAM 9.S3D3.800

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTCAM9S3D33001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
CAM 9.S3D3.300
In Commercial Distribution

  • ENTTCAM9S3D33001 ()

  • CAM-Series 3,3 mm
CAM 9.S3D3.300

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTBRE9S3D35401

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
BRE 9.S3D3.540
In Commercial Distribution

  • ENTTBRE9S3D35401 ()

  • BRE-Series 4,0 mm
BRE 9.S3D3.540

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTBIO9S3D57001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
BIO 9.S3D5.700
In Commercial Distribution

  • ENTTBIO9S3D57001 ()

  • BIO-Series 5,7 mm
BIO 9.S3D5.700

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTBIO9S3D45001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
BIO 9.S3D4.500
In Commercial Distribution

  • ENTTBIO9S3D45001 ()

  • BIO-Series 4,5 mm
BIO 9.S3D4.500

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTBIO9S3D35001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
BIO 9.S3D3.500
In Commercial Distribution

  • ENTTBIO9S3D35001 ()

  • BIO-Series 3,5 mm
BIO 9.S3D3.500

  • Dental implant abutment analog, intraoral-scanning, single-use

NA - ENTTBIO9S3D30001

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
BIO 9.S3D3.000
In Commercial Distribution

  • ENTTBIO9S3D30001 ()

  • BIO-Series 3,0 mm
BIO 9.S3D3.000

  • Dental implant abutment analog, intraoral-scanning, single-use
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