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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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Vectre - 00815361020242

Vectre Screw Set, 30 mm (2 pk) with perm washer
QUANDARY MEDICAL LLC
24-8001
In Commercial Distribution

  • 00815361020242 ()


  • Bone-screw internal spinal fixation system, sterile

Vectre - 00815361020235

Vectre Screw Set, 25 mm (2 pk) with perm washer
QUANDARY MEDICAL LLC
24-8000
In Commercial Distribution

  • 00815361020235 ()


  • Bone-screw internal spinal fixation system, sterile

N/A - 00885825016319

Ultrasonic Scalpel Curved Shears With Erg Handle And Curved Blade
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
Not in Commercial Distribution

  • 30885825016310 ()
  • 00885825016319 ()

  • Length: 36.0 Centimeter
ACE36E

  • Soft-tissue ultrasonic surgical system holder/tip, reprocessed

N/A - 00885825016302

Ultrasonic Scalpel Curved Shears With Erg Handle And Curved Blade
STRYKER SUSTAINABILITY SOLUTIONS, INC.
N/A
Not in Commercial Distribution

  • 30885825016303 ()
  • 00885825016302 ()

  • Length: 23.0 Centimeter
ACE23E

  • Soft-tissue ultrasonic surgical system holder/tip, reprocessed

LIFECODES HLA-DRB1 SSO Typing Kit for use with Lumine - 10888234400066

DNA Typing of Class II HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628923
Not in Commercial Distribution

  • 10888234400066 ()
628923

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

LIFECODES HLA-B SSO Typing Kit for use with Luminex - 10888234400028

DNA Typing of Class I HLA alleles, to aid in transfusion and transplantation donor and recipient matching
IMMUCOR GTI DIAGNOSTICS, INC.
628915
Not in Commercial Distribution

  • 10888234400028 ()
628915

  • DNA-based tissue typing IVD, kit, nucleic acid technique (NAT)

Neptune ® Comfort Band with Calcium Alginate Wound Dressing - 10811331010166

Neptune ® Comfort Band with Calcium Alginate Wound Dressing 17 inch Sterile
Tz Medical, Inc.
CB-8517N
In Commercial Distribution

  • 00811331010169 ()
  • 10811331010166 ()


  • Wound compression dressing

MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs - 00081317003793

SILTEX Medium Height Tissue Expander Style 7300, 850cc
MENTOR TEXAS L.P.
3547317
Not in Commercial Distribution

  • 00081317003793 ()
354-7317

  • Skin-port tissue expander

MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs - 00081317003786

SILTEX Medium Height Tissue Expander Style 7300, 750cc
MENTOR TEXAS L.P.
3547316
Not in Commercial Distribution

  • 00081317003786 ()
354-7316

  • Skin-port tissue expander

MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs - 00081317003779

SILTEX Medium Height Tissue Expander Style 7300, 650cc
MENTOR TEXAS L.P.
3547315
Not in Commercial Distribution

  • 00081317003779 ()
354-7315

  • Skin-port tissue expander
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