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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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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

Marienfeld Superior - 04250317320445

No Description
Paul Marienfeld GmbH & Co. KG
9 N.1,5
In Commercial Distribution

  • 04250317365118 ()
  • 04250317320445 ()
0112990492

  • Microscope slide coverslip IVD

Spectra - 08809108016447

This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra 9 Plus
In Commercial Distribution

  • 28809108016441 ()
  • 08809108016447 ()
MM011343

  • Breast pump, electric

Spectra - 08809108011350

This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra 9 Plus
In Commercial Distribution

  • 28809108011354 ()
  • 18809108011357 ()
  • 08809108011350 ()
  • 18809108013030 ()
  • 28809108013037 ()


  • Breast pump, electric

Spectra - 08809108011343

This is powered breast pump to be used by lactating women to express and collect milk from their breasts. The final product is packed in a box with neccessary connecting parts including breast shield, head, membrane, tubing, backflow protector,bottle, and instruction for use, so the user can use the device right after receving them.
UZINMEDICARE CO.,LTD
Spectra 9 Plus
In Commercial Distribution

  • 18809108011340 ()
  • 08809108011343 ()
  • 28809108011347 ()


  • Breast pump, electric

Marienfeld Superior - 04064279011668

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

  • 04064279011644 ()
  • 04064279011668 ()
0895003

  • Microscope slide coverslip IVD

Marienfeld Superior - 04250317364180

No Description
Paul Marienfeld GmbH & Co. KG
9 N.1,5H
In Commercial Distribution

  • 04250317365057 ()
  • 04250317364180 ()
011799091

  • Microscope slide coverslip IVD

Marienfeld Superior - 04250317356444

No Description
Paul Marienfeld GmbH & Co. KG
9 N.3
In Commercial Distribution

  • 04250317364951 ()
  • 04250317356444 ()
0114990090

  • Microscope slide coverslip IVD

Marienfeld Superior - 04250317328168

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

  • 04250317365491 ()
  • 04250317328168 ()
011199039169

  • Microscope slide coverslip IVD

NA - 00724995001551

The Flow Units are accessories that facilitate use of the Reliance EPS processor with specific endoscopes and endoscope accessory parts.
Corporation Steris Canada
Flow Unit 9
Not in Commercial Distribution

  • 00724995001551 ()
EPSC009INT

  • Luminal device flushing tubing set, reusable

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

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

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

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

MulTipeg™ - 07350096321194

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

  • 07350096321194 ()
55019

  • Multimeter

ASSORTED BRANDS - 00193033109755

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

  • 00193033109755 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00193033448052

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

  • 00193033448052 ()


  • Tinted non-prescription spectacles

PAINfusor Catheter - 08056459671249

The PAINfusor Catheter, along with related accessory devices, is intended for use to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around a surgical wound size for preoperative, perioperative and postoperative pain management. Routes of administration may be intraoperative or percutaneous. The PAINfusor Catheter is contraindicated for vascular or epidural drug administration for the delivery and withdrawal of dense fluids like blood, lipids and fat emulsions, and for use in neonatal population.
PLAN 1 HEALTH S.R.L.
22.5 cm - 9"
In Commercial Distribution

  • 08056459671249 ()
  • 18056459671246 ()

  • Length: 22.5 Centimeter
  • Length: 9 Inch
203.06.10.22US

  • Anaesthesia conduction catheterization kit

Boule Con-Diff Tri-Level - 00812137010230

For in vitro diagnostic use as a control to monitor the performance of multi- parameter hematology instruments. Boule Con-Diff Hematology Control is prepared from stabilized human blood so that repeated measurements can be made daily to monitor the performance of hematology analyzer systems. ASSIGNED VALUES and EXPECTED RANGES are determined on systems using specific Boule reagents. ASSIGNED VALUES are confirmed by multiple analysis of the control product.
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
9 x 4.5mL
In Commercial Distribution

  • 00812137010230 ()
  • 00812137011800 ()
501-607

  • Full blood count IVD, control

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

UNBRANDED - 00887661217653

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

  • 00887661217653 ()


  • Tinted non-prescription spectacles

ASSORTED BRANDS - 00887661635082

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

  • 00887661635082 ()


  • Tinted non-prescription spectacles

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

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

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

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

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

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

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

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

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

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
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