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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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Ambler Surgical - 00190660092399

#9 knife handle, 4 3/4'', delicate, for blades 10, 11, 12 and 15, flat handle
AMBLER SURGICAL CORP.
#9 knife handle
In Commercial Distribution

  • 00190660092399 ()
38-135

  • Scalpel handle, reusable

ASSORTED BRANDS - 00193033007280

No Description
FGX INTERNATIONAL INC.
DL4732/9.FTG
In Commercial Distribution

  • 00193033007280 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033014370

No Description
FGX INTERNATIONAL INC.
DL4746/9.AUT
In Commercial Distribution

  • 00193033014370 ()


  • Prescription spectacles

ATHLET - 04047844002407

The ATHLET VBR System is a lordotic, modular vertebral body replacement system. Caudal and cranial components are offered in a variety of heights and are assembled to create a device construct. An intermediate component is also available and is used between one caudal and one cranial component. The device construct comprises a central cannula for bone graft and lateral fenestrations for bony in-growth.
SIGNUS Medizintechnik GmbH
Main body 9
In Commercial Distribution

  • 04047844002407 ()

  • 42x14x15mm
AT0942

  • Vertebral body prosthesis

ASSORTED BRANDS - 00193033448052

No Description
FGX INTERNATIONAL INC.
DL5582/9.FTG
In Commercial Distribution

  • 00193033448052 ()


  • Tinted non-prescription spectacles

A. Titan Instruments - 00841685104252

Plugger, double ended, plugger/explorer
A. TITAN INSTRUMENTS, INC.
RCP 9/11
In Commercial Distribution

  • 00841685104252 ()


  • Endodontic plugger

A. Titan Instruments - 00841685104054

Periodontal File, Schluger, double ended
A. TITAN INSTRUMENTS, INC.
Schluger 9/10
In Commercial Distribution

  • 00841685104054 ()


  • Margin finishing dental file/rasp, reusable

ASSORTED BRANDS - 00193033543900

No Description
FGX INTERNATIONAL INC.
DL5812/9.FTG
In Commercial Distribution

  • 00193033543900 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033543894

No Description
FGX INTERNATIONAL INC.
DL5816/9.FTG
In Commercial Distribution

  • 00193033543894 ()


  • Tinted non-prescription spectacles

ABSORBENT PAPER POINTS - 08806383514163

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PRO-.06 9
In Commercial Distribution

  • 08806383514163 ()
206-609

  • Endodontic paper point

ABSORBENT PAPER POINTS - 08806383514057

"An absorbent paper points is an endodontic paper point that is used during the endodontic therapy to dry, or remove any foreign materials from the root canal of a tooth."
DiaDent Group International
DIA-PRO-.04 9
In Commercial Distribution

  • 08806383514057 ()
205-609

  • Endodontic paper point

GUTTA PERCHA POINTS - 08806383504065

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-PRO-.06 9
In Commercial Distribution

  • 08806383504065 ()
110-609

  • Natural gutta-percha

GUTTA PERCHA POINTS - 08806383503952

Gutta Percha Points is used to root canal filing material.
DiaDent Group International
DIA-PRO-.04 9
In Commercial Distribution

  • 08806383503952 ()
109-609

  • Natural gutta-percha

ASSORTED BRANDS - 00193033511572

No Description
FGX INTERNATIONAL INC.
DL5660/9.CGR
In Commercial Distribution

  • 00193033511572 ()


  • Tinted non-prescription spectacles

ASIA MED - 04251282507787

asia-med Standard No. 9: uncoated acupuncture needles with copper-wire handle|without guide tube|Packaging: 1 needle per blister|Size: Gauge 10(x 2.0") / 0.35 x 50 mm|Color code: black|Sales unit: 100 pieces
asia-med GmbH
Standard No. 9
In Commercial Distribution

  • 04251282500467 ()
  • 04251282507794 ()
  • 04251282507787 ()
  • 04251282507770 ()

  • Length: 50 Millimeter
  • Outer Diameter: 0.35 Millimeter
A000363

  • Acupuncture needle, single-use

ASIA MED - 04251282500467

asia-med Standard No. 9: uncoated acupuncture needles with copper-wire handle|without guide tube|Packaging: 1 needle per blister|Size: Gauge 10(x 2.0") / 0.35 x 50 mm|Color code: black|Sales unit: 100 pieces
asia-med Gesellschaft für Akupunkturbedarf mbH & Co. KG
Standard No. 9
Not in Commercial Distribution

  • 04251282500467 ()
  • 04251282500450 ()

  • Length: 50 Millimeter
  • Outer Diameter: 0.35 Millimeter
A000363

  • Acupuncture needle, single-use

ASSORTED BRANDS - 00193033109755

No Description
FGX INTERNATIONAL INC.
DL4972/9.FWG
In Commercial Distribution

  • 00193033109755 ()


  • Tinted non-prescription spectacles

CarboClear Lumbar Cage System - 07290110206437

A surgical tool intended for discectomy and eroding of the lumbar cage endplate. Once rotated, the Shaver width also enables estimation of the intervertebral space height.
CARBOFIX ORTHOPEDICS LTD
Shaver – 9 mm
In Commercial Distribution

  • 07290110206437 ()
CCLC9009

  • Bone curette, reusable

ASSORTED BRANDS - 00887661635082

No Description
FGX INTERNATIONAL INC.
DL4719/9.FTG
In Commercial Distribution

  • 00887661635082 ()


  • Tinted non-prescription spectacles

UNBRANDED - 00887661217653

No Description
FGX INTERNATIONAL INC.
DL4033/9.FTG
In Commercial Distribution

  • 00887661217653 ()


  • Tinted non-prescription spectacles

MulTipeg™ - 07350096321194

No Description
Integration Diagnostics Sweden AB
MulTipeg™ 9
In Commercial Distribution

  • 07350096321194 ()
55019

  • Multimeter

N/A - ENTTTA9S3D3745

Scanbody 3D-Guide®
NT-Trading GmbH & Co. KG
TA 9.S33D3.745
In Commercial Distribution

  • ENTTTA9S3D3745 ()

  • Outer Diameter: 3.7 Millimeter
  • Outer Diameter: 4.0 Millimeter
  • Outer Diameter: 4.5 Millimeter
  • Outer Diameter: 5.0 Millimeter
  • Outer Diameter: 6.0 Millimeter
  • Outer Diameter: 7.0 Millimeter
  • Outer Diameter: 8.0 Millimeter


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

Passeo-35 - 07640119558158

No Description
Biotronik AG
9/20/80
Not in Commercial Distribution

  • 07640119558158 ()

  • Diameter: 9 mm
  • Usable Length: 80 cm
  • Length: 20 mm
357286

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640119558219

No Description
Biotronik AG
9/40/80
Not in Commercial Distribution

  • 07640119558219 ()

  • Usable Length: 80 cm
  • Length: 40 mm
  • Diameter: 9 mm
357292

  • Peripheral angioplasty balloon catheter, basic

Marienfeld Superior - 04064279011668

No Description
Paul Marienfeld GmbH & Co. KG
9 N.1
In Commercial Distribution

  • 04064279011644 ()
  • 04064279011668 ()
0895003

  • Microscope slide coverslip IVD

Avaline Medical NJ LLC - 00810124536282

Paper Surgical Tape with Dispenser 1"x10 Yards
Avaline Medical NJ Limited Liability Company
1in+DIP +9
In Commercial Distribution

  • 00810124536329 ()
  • 00810124536282 ()


  • Multi-purpose surgical skin adhesive tape

Avaline Medical NJ LLC - 00810124535933

Paper Surgical Tape with Dispenser 2"x10 Yards
Avaline Medical NJ Limited Liability Company
2in+DIP +9
In Commercial Distribution

  • 00810124536336 ()
  • 00810124535933 ()


  • Multi-purpose surgical skin adhesive tape

ProCure - 10840330702987

ProCure - Soft Silicone Foam Dressing w/Border Sacral Large 9"x 9" - 5ea/bx 40bx/cs
Twin Med, LLC
PCHF3311
In Commercial Distribution

  • 30840330702981 ()
  • 10840330702987 ()
  • 50840330702985 ()

  • Width: 9 Inch
  • Length: 9 Inch
PCHF3311

  • Exudate-absorbent dressing, hydrophilic-gel, non-antimicrobial

CONMED - 10845854041666

HIGH STRENGTH BREAKAWAY GUIDE PIN, 9 IN, STERILE, 2.4 X 229 MM (.093 X 9 IN)
Conmed Corporation
9743D
In Commercial Distribution

  • 20845854041663 ()
  • 10845854041666 ()
  • 00845854041669 ()
9743D

  • Orthopaedic guidewire, single-use

AESCULAP - 04038653175345

DESMARRES Lid Retractor, 5 1/2", (140 mm), depth: 9 mm, width: 9 mm, non-sterile, reusable
Aesculap AG
OA310R
In Commercial Distribution

  • 04038653175345 ()
OA310R

  • Nerve/vessel retractor

Surgical Direct - B382SD9026931010

7 1/2 Inch Cushing-Brown Bayonet Tissue Forcep, Double Row 9 x 9 Teeth, Scraper End
Surgical Direct, Inc.
SD902693101
In Commercial Distribution

  • B382SD9026931010 ()
SD902693101

  • Dressing/utility forceps, scissors-like, reusable

Hayden Medical - 00840319743256

Hurd Tonsil Dissector and Pillar Retractor 9" (22.5cm), standard pattern, 9 x 25mm blade, 13mm retractor
Hayden Medical, Inc.
202-854
In Commercial Distribution

  • 00840319743256 ()
202-854

  • Hand-held surgical retractor, reusable

Mini Master Series - 00190746108129

DB BKT MINI MS UL LAT 022 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1074B
In Commercial Distribution

  • 00190746108129 ()
390-1074B

  • Orthodontic bracket, metal

Mini Master Series - 00190746108105

DB BKT MINI MS UL LAT 018 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1064B
In Commercial Distribution

  • 00190746108105 ()
390-1064B

  • Orthodontic bracket, metal

Mini Master Series - 00190746108082

DB BKT MINI MS UR LAT 022 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1073B
In Commercial Distribution

  • 00190746108082 ()
390-1073B

  • Orthodontic bracket, metal

Mini Master Series - 00190746108068

DB BKT MINI MS UR LAT 018 T+9 A+9 R=0 W/HK DIST
AMERICAN ORTHODONTICS CORPORATION
390-1063B
In Commercial Distribution

  • 00190746108068 ()
390-1063B

  • Orthodontic bracket, metal

Novo Surgical - G586N684024XL0

frazier suction tube, straight, 9 fr., working length 6 3/4" (17.1 cm), 9" (22.9 cm)
NOVO SURGICAL, INC.
N6840-24XL
In Commercial Distribution

  • G586N684024XL0 ()
N6840-24XL

  • Surgical/emergency suction cannula, non-illuminating, reusable

Symmetry Gillies - 00887482050590

Symmetry® Elevator, Gillies Zygoma, Angle To Tip 35 mm, 9 mm Tip Width, 9 in
SYMMETRY SURGICAL INC.
68-4510
In Commercial Distribution

  • 00887482050590 ()

  • Length: 9 Inch
  • Width: 9 Millimeter
68-4510

  • Bone lever/elevator, reusable

Symmetry Ferguson - 00887482174708

Symmetry® Scoop, Ferguson Gall Stone, Double-Ended, 9 mm & 11 mm, Small, 9 1/2 in
SYMMETRY SURGICAL INC.
51-1501
In Commercial Distribution

  • 00887482174708 ()

  • Length: 9.5 Inch
  • Circumference: 9 Millimeter
  • Circumference: 11 Millimeter
51-1501

  • Gallstone scoop

Simpex Steinmann Pin - B068T140S1

Smooth Steinmann Pin, Single Trocar Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
T-140-S
In Commercial Distribution

  • B068T140S1 ()

  • Outer Diameter: 3.6 Millimeter
  • Length: 229 Millimeter
T-140-S

  • Orthopaedic bone pin, non-bioabsorbable

Simpex Steinmann Pin - B068T1401

Smooth Steinmann Pin, Double Trocar Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
T-140
In Commercial Distribution

  • B068T1401 ()

  • Length: 229 Millimeter
  • Outer Diameter: 3.6 Millimeter
T-140

  • Orthopaedic bone pin, non-bioabsorbable

Simpex Steinmann Pin - B068D140S1

Smooth Steinmann Pin, Single Diamond Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
D-140-S
In Commercial Distribution

  • B068D140S1 ()

  • Length: 229 Millimeter
  • Outer Diameter: 3.6 Millimeter
D-140-S

  • Orthopaedic bone pin, non-bioabsorbable

Simpex Steinmann Pin - B068D1401

Smooth Steinmann Pin, Double Diamond Tip; 9/64" DIA x 9" LG; Material: 316L Stainless Steel
SIMPEX MEDICAL, INC.
D-140
In Commercial Distribution

  • B068D1401 ()

  • Outer Diameter: 3.6 Millimeter
  • Length: 229 Millimeter
D-140

  • Orthopaedic bone pin, non-bioabsorbable

Symmetry Faulkner - 00887482118948

Symmetry® Curette, Faulkner Antrum, Double-Ended, 6 mm x 9 mm Rings, Malleable Shaft, 9 in
SYMMETRY SURGICAL INC.
63-7501
In Commercial Distribution

  • 00887482118948 ()

  • Width: 6 Millimeter
  • Depth: 9 Millimeter
  • Length: 9 Inch
63-7501

  • Bone curette, reusable

JAGUAR LUMBAR I/F CAGE - 10705034186849

JAGUAR LUMBAR I/F CAGE SYSTEM WEDGED TRIAL SPACER 9 x (9 x 13) x 25mm
DEPUY SPINE, LLC
273125409
Not in Commercial Distribution

  • 10705034186849 ()
273125409

  • Spinal implant trial

Persona® - 00889024560499

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

Persona® - 00889024560475

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

Persona® - 00889024560451

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

Persona® - 00889024557956

No Description
Zimmer, Inc.
42-5892-009-30
In Commercial Distribution

  • 00889024557956 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / G, H
42-5892-009-30

  • Knee tibia prosthesis trial, reusable

Persona® - 00889024557932

No Description
Zimmer, Inc.
42-5892-007-30
In Commercial Distribution

  • 00889024557932 ()

  • Sizes 6, 7, 7+, 8, 9, 9+ / E, F
42-5892-007-30

  • Knee tibia prosthesis trial, reusable
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