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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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Natrelle® Style 133 Tissue Expanders with Suture Tabs - 10888628004238

NATRELLE 133FV With Sut Tab, 400cc
Allergan, Inc.
133FV-12-T
Not in Commercial Distribution

  • 10888628004238 ()

  • 400 cc
133FV-12-T

  • Skin-port tissue expander

Natrelle® Style 133 Tissue Expanders with Suture Tabs - 10888628004221

NATRELLE 133FV With Sut Tab, 300cc
Allergan, Inc.
133FV-11-T
Not in Commercial Distribution

  • 10888628004221 ()

  • 300 cc
133FV-11-T

  • Skin-port tissue expander

SonicOne O.R. - 00841626101340

SonicOne O.R. Debridement Probe With Aspiration
MISONIX, INC.
MXC-X2-VAC
In Commercial Distribution

  • 00841626101340 ()
  • 10841626101347 ()


  • Soft-tissue ultrasonic surgical system handpiece tip, single-use

Retrax Pellets - 00310866000800

Hemostatic cotton pellets with aluminum sulfate
PASCAL COMPANY, INC.
12400
In Commercial Distribution

  • 00310866000800 ()
  • 00310866002019 ()
12400

  • Gingival retraction cord, medicated

Dilution Solution - 10888234500827

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515UDI
In Commercial Distribution

  • 10888234500827 ()
628515UDI

  • Buffered sample diluent IVD

Dilution Solution - 10888234400769

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628515
In Commercial Distribution

  • 10888234400769 ()
628515

  • Buffered sample diluent IVD

Dilution Solution - 10888234400745

For Use with HLA-SSO Typing Kits
IMMUCOR GTI DIAGNOSTICS, INC.
628155
Not in Commercial Distribution

  • 10888234400745 ()
628155

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

Negative Control Serum - 10888234400547

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628214
Not in Commercial Distribution

  • 10888234400547 ()
628214

  • HLA class I & II antigen tissue typing IVD, kit, multiplex

LIFECODES Wash Buffer - 10888234400516

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628211
In Commercial Distribution

  • 10888234400516 ()
628211

  • Buffered wash solution IVD

Positive Control Serum - 10888234400523

For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628213
Not in Commercial Distribution

  • 10888234400523 ()
628213

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
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