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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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7-core EGFR Cell Line Microarray Control Slides - B502BSB02950

7-core EGFR Cell Line Microarray cell line cores assembled in array fashion used as control
BIO SB, INC.
Control Slides, 5
In Commercial Distribution

  • B502BSB02950 ()
BSB 0295

  • Biological stain control IVD

Renamel Microhybrid Pedo Kit - D779606PED3

Renamel Microhybrid Pedo Kit includes 5 (5 g) syringes of Renamel Microhybrid in the Tray.
COSMEDENT, INC.
606PED
In Commercial Distribution

  • D779606PED3 ()
606PED

  • Dental composite resin

Vinyl Lead Gloves - G031100VRL0

100V - 15" one piece, dip-molded glove with vinyl cover and foam liner - Sold in pairs
Shielding International Inc.
100VRL
In Commercial Distribution

  • G031100VRL0 ()


  • Radiation-shielding procedure preparation glove/mitten

HELMUT ZEPF - EZPF1270100Z0

EXTRACTING FORCEPS KIT, TWIST EX SET 1, IN BASKET, INCLUDING FOLLOWING ITEMS 12.034.00Z, 12.035.00Z, 12.036.00Z,
Helmut Zepf Medizintechnik GmbH
12.701.00Z
In Commercial Distribution

  • EZPF1270100Z0 ()
12.701.00Z

  • Tooth extraction forceps

Borrelia B31 IgG ViraStripe® Test Kit - EVIRBBSGUS1

Immunoassay for the detection of IgG antibodies against Borrelia burgdorferi s.s. / B31 in human serum.
Viramed Biotech AG
V-BBSGUS
In Commercial Distribution

  • EVIRBBSGUS1 ()

  • 50 tests
V-BBSGUS

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot

Borrelia B31 ViraChip® IgM Test Kit - EVIRBBCMOK1

Immunoassay for the detection of IgM antibodies against Borrelia burgdorferi s.s. / B31 in human serum.
Viramed Biotech AG
V-BBCMOK
In Commercial Distribution

  • EVIRBBCMOK1 ()

  • 96 tests
V-BBCMOK

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot

Borrelia B31 ViraChip IgG Test Kit - EVIRBBCGOK1

Immunoassay for the detection of IgG antibodies against Borrelia burgdorferi s.s. / B31 in human serum.
Viramed Biotech AG
V-BBCGOK
In Commercial Distribution

  • EVIRBBCGOK1 ()

  • 96 tests
V-BBCGOK

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot

Borrelia B31 ViraChip IgG Deca Kit - EVIRBBCGDK1

Immunoassay for the detection of IgG antibodies against Borrelia burgdorferi s.s. / B31 in human serum.
Viramed Biotech AG
V-BBCGDK
In Commercial Distribution

  • EVIRBBCGDK1 ()

  • 960 tests
V-BBCGDK

  • Borrelia burgdorferi total antibody IVD, kit, immunoblot

Smart-Read EZTest Steam - M985SEZS5251

Self-contained biological indicator for use in steam sterilization processes. Log 5 population. 25 count box.
MESA LABORATORIES, INC.
Log 5
In Commercial Distribution

  • M985SEZS5251 ()
  • M985SEZS5250 ()
SEZS/525

  • Biological sterilization indicator

HELMUT ZEPF - EZPF47990000

KRASTEV VGO OST SET STRAIGHT SCREW OSTEOTOME INSERTS EXCHANGEABLE INCLUDING 2 HANDLES IN A WASHBASKET
Helmut Zepf Medizintechnik GmbH
47.990.00
In Commercial Distribution

  • EZPF47990000 ()
47.990.00

  • Periosteal elevator, reusable
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