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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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Biotronik Passeo-35 HP - 05391525781594

No Description
CREAGH MEDICAL LIMITED
9/40/75
In Commercial Distribution

  • 05391525781594 ()

  • Usable Length: 75 cm
  • Length: 40 Millimeter
  • Outer Diameter: 9.0 Millimeter
399095

  • Peripheral angioplasty balloon catheter, basic

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

HairMax - 00856823006534

Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT)
Lexington International, LLC
Ultima 9 Classic
In Commercial Distribution

  • 00856823006534 ()
856823006534

  • Hair growth laser device

Epredia - 00673693089029

The Paraffin line is specially designed for tissue processing and embedding of histological and cytological specimens. The product is a white solid at room temperature and a clear, liquid when molten. The paraffin can be used with both open and closed tissue processors. It is also compatible with all embedding centers and manual embedding techniques. Paraffin is used in tissue processing during the infiltration steps. Melting points and polymer content differ between formulations. Choosing which type of paraffin may depend on the tissue density or personal preference of the histotechnician. Softer kinds of paraffin with less polymer tend to infiltrate tissue slightly quicker during processing but yield a softer block during embedding. Softer kinds of paraffin better lend themselves to thicker sections during microtomy. Harder kinds of paraffin with a higher polymer content usually take a little more time to infiltrate the tissue during processing but yield harder blocks that allow thinner sectioning during microtomy. Harder tissue specimens are better supported with a harder paraffin block.
RICHARD-ALLAN SCIENTIFIC COMPANY
Paraffin, Type 9
In Commercial Distribution

  • 00673693089029 ()
8337

  • Paraffin-based embedding medium IVD

Encore - 00850358007264

No Description
ENCORE, INC.
SILICONE RING #9
In Commercial Distribution

  • 00850358007264 ()
44003-9-001

  • Penile vacuum device

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

A. Titan Instruments - 00841685104252

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

  • 00841685104252 ()


  • Endodontic plugger

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

Marienfeld Superior - 04250317328168

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

  • 04250317365491 ()
  • 04250317328168 ()
011199039169

  • Microscope slide coverslip IVD

Marienfeld Superior - 04250317320445

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

  • 04250317365118 ()
  • 04250317320445 ()
0112990492

  • 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

HYPE SCV - 03662200025947

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCV 9
In Commercial Distribution

  • 03662200025947 ()


  • Press-fit femoral stem prosthesis

HYPE SCL - 03662200025855

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCL 9
In Commercial Distribution

  • 03662200025855 ()


  • Press-fit femoral stem prosthesis

HYPE SCC - 03662200025756

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCC 9
In Commercial Distribution

  • 03662200025756 ()


  • Press-fit femoral stem prosthesis

HYPE SCS - 03662200025640

No Description
SOC ETUDES RECHERCHES FABRICATION
HYPE SCS 9
In Commercial Distribution

  • 03662200025640 ()


  • Press-fit femoral stem prosthesis

Excyte 20 - 03661540304422

Automated Erythrocyte Sedimentation Rate (ESR) Analyzer
ELITECHGROUP INC.
20 (9 mm)
In Commercial Distribution

  • 03661540304422 ()
EX-10618

  • Erthrocyte sedimentation rate (ESR) analyser IVD

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

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

Marienfeld Superior - 04064279011668

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

  • 04064279011644 ()
  • 04064279011668 ()
0895003

  • Microscope slide coverslip IVD

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 - 00193033109755

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

  • 00193033109755 ()


  • Tinted non-prescription spectacles

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
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