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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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Caps Warmer - E22190021

Device for temporary heating of dental composites in order to improve application properties.
VOCO GmbH
9002
In Commercial Distribution

  • E22190021 ()


  • Anaesthesia warmer

Caps Warmer - E22190011

Device for temporary heating of dental composites in order to improve application properties.
VOCO GmbH
9001
In Commercial Distribution

  • E22190011 ()


  • Anaesthesia warmer

Coeur - M297101230

4 in Extension Line with Check Valve and Male Luer with Rotating Skirt
COEUR, INC.
C405-0123
In Commercial Distribution

  • M297101236 ()
  • M297101235 ()
  • M297101230 ()

  • Length: 4 Inch
C405-0123

  • Radiographic procedure tubing

Surgical Direct - B382SD501011SM660

4mm 66cm New Catheter Passer, Shunt Guide with Hole in Tip, and T-Handle
Surgical Direct, Inc.
SD50-1011SM-66
In Commercial Distribution

  • B382SD501011SM660 ()
SD50-1011SM-66

  • Vascular graft tunneller

BodyGuard® Microset - B101A100163XE90S0

90 in. (230 cm) - yellow stripe, For Use with the BodyGuard® Pump
CME AMERICA LLC
A100-163XE90S
Not in Commercial Distribution

  • B101A100163XE90S1 ()
  • B101A100163XE90S0 ()


  • Electric infusion pump administration set, single-use

InTray® DM - B08820630

An enriched dermatophyte medium used in the detection of dermatophytes from clinical specimens.
BIO-MED DIAGNOSTICS, INC.
2063
In Commercial Distribution

  • B08820630 ()
  • B08820634 ()
  • B08820632 ()
22-063-000

  • Multiple dermatophyte species culture isolate identification IVD, kit

NA - B261CANT342200

TRIIODOTHYRONINE (T3) ELISA KIT FOR THE QUANTITATIVE MEASUREMENT OF TRIIODOTHYRONINE IN HUMAN SERUM
Diagnostics Biochem Canada Inc
CAN-T3-4220
In Commercial Distribution

  • B261CANT342200 ()
CAN-T3-4220

  • Total triiodothyronine (TT3) IVD, kit, enzyme immunoassay (EIA)

Extraction Buffer 4X, 55mL Fill - B24210EXBUF550

General purpose reagent used in preparation of samples for ALPCO stool-based biomarker kits.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
10-EXBUF-55
In Commercial Distribution

  • B24210EXBUF550 ()
10-EXBUF-55

  • Clinical specimen extraction buffer IVD

Extraction Buffer 4X, 225mL Fill - B24210EXBUF2250

General purpose reagent used in preparation of samples for ALPCO stool-based biomarker kits.
AMERICAN LABORATORY PRODUCTS COMPANY, LTD.
10-EXBUF-225
In Commercial Distribution

  • B24210EXBUF2250 ()
10-EXBUF-225

  • Clinical specimen extraction buffer IVD

STERIDENT - B234FRGSTMS400634

SPORE TEST KIT MONITORING SERVICE DRY HEAT OR STEAM, MAIL IN 52/BOX
CPAC EQUIPMENT, INC.
400634
In Commercial Distribution

  • B234FRGSTMS400634 ()


  • Biological sterilization indicator
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