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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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Capture - D745701031CAP00270

Medium Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0027
In Commercial Distribution

  • D745701031CAP00141 ()
  • D745701031CAP00270 ()
  • D745701028CAP00101 ()
70-1031-CAP0027

  • Silicone dental impression material

Capture - D745701031CAP00260

Light Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0026
In Commercial Distribution

  • D745701031CAP00091 ()
  • D745701031CAP00260 ()
  • D745701028CAP00081 ()
70-1031-CAP0026

  • Silicone dental impression material

Capture - D745701031CAP00250

Light Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0025
In Commercial Distribution

  • D745701031CAP00101 ()
  • D745701031CAP00250 ()
  • D745701028CAP00061 ()
70-1031-CAP0025

  • Silicone dental impression material

Capture - D745701031CAP00240

Heavy Crown Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0024
In Commercial Distribution

  • D745701031CAP00051 ()
  • D745701028CAP00041 ()
  • D745701031CAP00240 ()
70-1031-CAP0024

  • Silicone dental impression material

Capture - D745701031CAP00230

Heavy Bridge Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0023
In Commercial Distribution

  • D745701031CAP00061 ()
  • D745701028CAP00021 ()
  • D745701031CAP00230 ()
70-1031-CAP0023

  • Silicone dental impression material

Capture - D745701031CAP00220

Hard Bite Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0022
In Commercial Distribution

  • D745701031CAP00031 ()
  • D745701032CAP00021 ()
  • D745701031CAP00220 ()
70-1031-CAP0022

  • Silicone dental impression material

Capture - D745701031CAP00210

Clear Bite Impression Material
Prismatik Dentalcraft, Inc
70-1031-CAP0021
In Commercial Distribution

  • D745701031CAP00210 ()
  • D745701032CAP00011 ()
  • D745701031CAP00011 ()
70-1031-CAP0021

  • Silicone dental impression material

SOLEIL - D74451287920

SOLEIL LED SLEEVE 135 BX500
BENCO DENTAL SUPPLY CO.
5128-792
In Commercial Distribution

  • D74451287922 ()
  • D74451287921 ()
  • D74451287920 ()


  • Instrument/equipment drape, single-use, non-sterile

SOLEIL - D74451184270

SOLEIL S1600 LED SLEEVES BX500
BENCO DENTAL SUPPLY CO.
5118-427
In Commercial Distribution

  • D74451184270 ()
  • D74451184271 ()
  • D74451184272 ()


  • Instrument/equipment drape, single-use, non-sterile

Tru-Incise Valvulotome with Interchangeable Heads - H862TIVH200

Tru-Incise 2mm Cutting Head
URESIL, LLC
TIVH20
Not in Commercial Distribution

  • H862TIVH202 ()
  • H862TIVH201 ()
  • H862TIVH200 ()

  • Outer Diameter: 2 Micrometer
TIVH20

  • Vein stripper, single-use

Atmos - E261UDA582450

Pump Tubing 5x8mm
BIOENGINEERING LABORATORIES SRL
UD-A58245
In Commercial Distribution

  • E261UDA582451 ()
  • E261UDA582450 ()
  • E261UDA582452 ()

  • Outer Diameter: 8 Millimeter


  • Urological irrigation set

Sutrasilk - M583S840821

8-0 Suture USP / Thread Specifications: Silk, Black Braided, 12 inch (30 cm) / Needle Specifications: ST-140-8, Spatula Tip, 3/8 circle (140 degrees), length 6 mm, wire 0.20mm / # of needles: Double arm
VISIONARY MEDICAL SUPPLIES INC
S84082
In Commercial Distribution

  • M583S840823 ()
  • M583S840822 ()
  • M583S840821 ()

  • Angle: 140 degree
  • 8-0 USP
  • Outer Diameter: 0.20 Millimeter
  • Length: 6.0 Millimeter
  • Length: 30 Centimeter


  • Silk suture

Axiom® Atraum™ With ClotStop® - M665111009AT0

Mediastinal Drain, Silicone, Eyes On Top Bottom & Sides, With ClotStop®
AXIOM MEDICAL, INCORPORATED
111009AT
In Commercial Distribution

  • M665111009AT3 ()
  • M665111009AT1 ()
  • M665111009AT0 ()

  • Lumen/Inner Diameter: 9 Millimeter


  • Mediastinal drainage catheter, non-antimicrobial

ScanX Swift Digital Imaging System - D678G80100

A device that scans photostimulable phosphor plates that have been exposed in the place of dental x-ray film and allows those images to be displayed on a CRT and stored for later recovery in a computer memory. It will be used by dentists and authorized dental auxiliary personnel for this purpose. This kit contains an installation disc, USB cable and power supply, PSPs, barrier envelopes, barrier film rolls, PSP wipes, and a scanner cleaning sheet.
AIR TECHNIQUES, INC.
G8010
In Commercial Distribution

  • D678G80001 ()
  • D678G80100 ()
  • D678G80101 ()

  • Weight: 14.5 Pound
  • Outer Diameter: 9.6 Inch
  • Height: 9.2 Inch
  • Width: 8.9 Inch


  • Radiography digital imaging scanner

Axiom® Clamp Sleeves - M6656200

Instrument Jaw Covers, Blue
AXIOM MEDICAL, INCORPORATED
620
In Commercial Distribution

  • M6656203 ()
  • M6656201 ()
  • M6656200 ()

  • Lumen/Inner Diameter: 0.3 Inch


  • Clamp jaw cover

Sutralon - M583N74092TP1

7-0 Suture USP / Thread Specifications: Nylon, Black Monofilament, 30 cm / Needle Specifications: TP-140-9, Taper Point Needle, 3/8 (140 degrees), length 6.00 mm, wire 0.23 mm / # of needles: Double Arm
VISIONARY MEDICAL SUPPLIES INC
N74092TP
In Commercial Distribution

  • M583N74092TP3 ()
  • M583N74092TP2 ()
  • M583N74092TP1 ()

  • Length: 30 Centimeter
  • Length: 6.00 Millimeter
  • Outer Diameter: 0.23 Millimeter
  • 7-0 USP
  • Angle: 140 degree


  • Nylon suture, non-bioabsorbable, monofilament

UtahLoop - H671DLPE110

Electrosurgical Loop Electrode, 25mm Wide X 22mm Deep, Round Loop, 11cm Shaft Length, with Safe-T-Gauge
UTAH MEDICAL PRODUCTS, INC.
LETZ Electrode
In Commercial Distribution

  • H671DLPE112 ()
  • H671DLPE111 ()
  • H671DLPE110 ()

  • Depth: 22 Millimeter
  • Width: 25 Millimeter
DLP-E11

  • Open-surgery electrosurgical electrode, monopolar, single-use

Movement and Compressions System (MAC) - B547RF14220

MAC Strap-Bariatric
Recovery Force, LLC
4
In Commercial Distribution

  • B547RF14227 ()
  • B547RF14220 ()
  • B547RF14402270 ()

  • Length: 921 Millimeter
RF1422

  • Intermittent venous compression system

Atmos - E261UDAELN0

Transparent extension line 1500mm
BIOENGINEERING LABORATORIES SRL
UD-AELN
In Commercial Distribution

  • E261UDAELN1 ()
  • E261UDAELN0 ()
  • E261UDAELN2 ()

  • Length: 1500 Millimeter


  • Urological pressure monitoring tubing set

CUSTOMED - M20890030477

CUSTOMFEEL LATEX POWDERED SURGICAL GLOVE 6.0
CUSTOMED INC
712057693047
In Commercial Distribution

  • M20890030477 ()
  • M20890030470 ()
  • M20890030471 ()
  • M20890030472 ()

  • Circumference: 6.0 Inch
9003047

  • Hevea-latex surgical glove, powdered

AHS - B031AHS3013RN0

NEEDLE,30 X 1/2
American Health Service Sales Corporation
AHS3013RN
In Commercial Distribution

  • B031AHS3013RN2 ()
  • B031AHS3013RN1 ()
  • B031AHS3013RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS2738RN0

NEEDLE,27 X 1.5
American Health Service Sales Corporation
AHS2738RN
In Commercial Distribution

  • B031AHS2738RN2 ()
  • B031AHS2738RN1 ()
  • B031AHS2738RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS2538RN0

NEEDLE,25 X 1.5
American Health Service Sales Corporation
AHS2538RN
In Commercial Distribution

  • B031AHS2538RN2 ()
  • B031AHS2538RN1 ()
  • B031AHS2538RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS2516RN0

NEEDLE,25 X 5/8
American Health Service Sales Corporation
AHS2516RN
In Commercial Distribution

  • B031AHS2516RN2 ()
  • B031AHS2516RN1 ()
  • B031AHS2516RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS2238RN0

NEEDLE,22 X 1.5
American Health Service Sales Corporation
AHS2238RN
In Commercial Distribution

  • B031AHS2238RN2 ()
  • B031AHS2238RN1 ()
  • B031AHS2238RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS2219RN0

NEEDLE,22 X 3/4
American Health Service Sales Corporation
AHS2219RN
In Commercial Distribution

  • B031AHS2219RN2 ()
  • B031AHS2219RN1 ()
  • B031AHS2219RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS2125RN0

NEEDLE,21 X 1
American Health Service Sales Corporation
AHS2125RN
In Commercial Distribution

  • B031AHS2125RN2 ()
  • B031AHS2125RN1 ()
  • B031AHS2125RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS1838RN0

NEEDLE,18 X 1.5
American Health Service Sales Corporation
AHS1838RN
In Commercial Distribution

  • B031AHS1838RN2 ()
  • B031AHS1838RN1 ()
  • B031AHS1838RN0 ()


  • Hypodermic needle, single-use

AHS - B031AHS1825RN0

NEEDLE,18 X 1
American Health Service Sales Corporation
AHS1825RN
In Commercial Distribution

  • B031AHS1825RN2 ()
  • B031AHS1825RN1 ()
  • B031AHS1825RN0 ()


  • Hypodermic needle, single-use

AHS - B031AH03L18380

SYRINGE,3CC,L/L,18 X 1.5
American Health Service Sales Corporation
AH03L1838
In Commercial Distribution

  • B031AH03L18382 ()
  • B031AH03L18380 ()
  • B031AH03L18381 ()


  • General-purpose syringe, single-use
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