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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ONE (1) PACKAGE - CONTAINING 5.0 CC
Xtant Medical Holdings, Inc.
SC-5205-DBM
In Commercial Distribution

  • 00849777013482 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 1.0cc (jar)
Xtant Medical Holdings, Inc.
GTR-01P
In Commercial Distribution

  • 00849777012225 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 1.0cc (jar)
Xtant Medical Holdings, Inc.
HG-01P
In Commercial Distribution

  • 00849777012218 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 5.0cc (jar)
Xtant Medical Holdings, Inc.
LD-600-050-M
In Commercial Distribution

  • 00849777012126 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 10.0cc (jar)
Xtant Medical Holdings, Inc.
LD-600-010-M
In Commercial Distribution

  • 00849777010238 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 1.0cc (jar)
Xtant Medical Holdings, Inc.
BM895010
In Commercial Distribution

  • 00849777009645 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 10cc - JAR
Xtant Medical Holdings, Inc.
HG-10P
In Commercial Distribution

  • 00849777009362 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 5.0cc - JAR
Xtant Medical Holdings, Inc.
HG-05P
In Commercial Distribution

  • 00849777009355 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 2.5cc - JAR
Xtant Medical Holdings, Inc.
HG-02P
In Commercial Distribution

  • 00849777009348 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 1.0cc (jar)
Xtant Medical Holdings, Inc.
LD-600-001-M
In Commercial Distribution

  • 00849777008648 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 5.0cc (jar)
Xtant Medical Holdings, Inc.
BX-600-050-M
In Commercial Distribution

  • 00849777008129 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 2.5cc (jar)
Xtant Medical Holdings, Inc.
BX-600-025-M
In Commercial Distribution

  • 00849777008112 ()


  • Bone matrix implant, human-derived
ONE (1) PACKAGE - CONTAINING 10.0cc (jar)
Xtant Medical Holdings, Inc.
BX-600-010-M
In Commercial Distribution

  • 00849777007856 ()


  • Bone matrix implant, human-derived
PR System One Style Foam Filter
SUNSET HEALTHCARE SOLUTIONS, INC.
BAY0151009F-1
In Commercial Distribution

  • 00848530092375 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ABUC001CF1009-2
In Commercial Distribution

  • 00848530092016 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA041CF1009NTPLC
In Commercial Distribution

  • 00848530091767 ()


  • CPAP/BPAP unit ambient air filter, single-use
PR System One Style Ultrafine Filters
SUNSET HEALTHCARE SOLUTIONS, INC.
ACPA050CF1009NTPLC
In Commercial Distribution

  • 00848530091750 ()


  • CPAP/BPAP unit ambient air filter, single-use
WIPE,MICRO-KILL ONE,7X8,FLAT PACK
MEDLINE INDUSTRIES, INC.
MSC351320
In Commercial Distribution

  • 20193489189541 ()
  • 10193489189544 ()
  • 80193489189543 ()
MSC351320

  • Medical device cleaning/disinfection wipe
iNAP One Sleep Therapy System Console
SOMNICS, INC.
R07-A
In Commercial Distribution

  • 04719878320122 ()
11000-7A

  • Intraoral negative-pressure sleep apnoea unit
iNAP One Sleep Therapy System Console
SOMNICS, INC.
R07-B
In Commercial Distribution

  • 04719878320023 ()
11000-07

  • Intraoral negative-pressure sleep apnoea unit
ONE SOURCE KIT ATLS34 AUTOLOG BT720
MEDTRONIC, INC.
ATLS34
In Commercial Distribution

  • 00613994710086 ()


  • Autotransfusion system blood component processing set
VT•200 SYS Global Med One
CARILEX MEDICAL, INC.
S1002-0082
In Commercial Distribution

  • 04719873696864 ()


  • Negative-pressure wound therapy system pump, electric
VT•200 P.U. Global Med One
CARILEX MEDICAL, INC.
S1002-3082
In Commercial Distribution

  • 04719873696857 ()


  • Negative-pressure wound therapy system pump, electric
ONE SOURCE PACK ATLS14 AUTOLOG BT715
MEDTRONIC, INC.
ATLS14
Not in Commercial Distribution

  • 00613994526380 ()


  • Autotransfusion system blood component processing set
INSTRUMENT 7480251 CNTRTRQ CNCTR ONE SD
MEDTRONIC SOFAMOR DANEK, INC.
7480251
Not in Commercial Distribution

  • 00613994197160 ()


  • Orthopaedic counter-torque/rod-pushing instrument
One Step Pregnancy Test, 2 count
GEISS, DESTIN & DUNN, INC
G600945
In Commercial Distribution

  • 00846036209457 ()
  • 00846036009453 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
One Step Pregnancy Test, 1 count
GEISS, DESTIN & DUNN, INC
G600944
In Commercial Distribution

  • 00846036009446 ()


  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical
CHI STD C SECTION OPTION ONE
Cardinal Health 200, LLC
CHIP99CS1D
In Commercial Distribution

  • 50887488546634 ()
  • 10887488546636 ()
CHIP99CS1D

  • Obstetrical/gynaecological surgical procedure kit, non-medicated, single-use
POINTED FORCEPS WITH ONE SERRATED JAW
Synthes GmbH
SD398.961
In Commercial Distribution

  • H679SD3989610 ()
  • 10886982006905 ()
SD398961

  • Bone holding forceps
MEDI-FRIG, ONE CANISTER (280G) W STRAW
Cynosure, LLC
H11B
In Commercial Distribution

  • 00841494103866 ()
H11B

  • Cryogenic spray, dental
One Step Dilator, 11/12 Fr.
Karl Storz GmbH & Co. KG
27820AB
In Commercial Distribution

  • 04048551347539 ()


  • Fascial tissue dilator, reusable
One Step Dilator, 8.5/9.5 Fr.
Karl Storz GmbH & Co. KG
27820AA
In Commercial Distribution

  • 04048551347522 ()


  • Fascial tissue dilator, reusable
Hook, one prong, sharp, 15 cm
Karl Storz GmbH & Co. KG
488555
In Commercial Distribution

  • 04048551322741 ()


  • Soft-tissue surgical hook, reusable
Mayo Scissors One Blade Serrated Straight
SONTEC INSTRUMENTS, INC.
110-273
In Commercial Distribution

  • 00192896119789 ()

  • Length: 6.75 Inch
110-273

  • General-purpose surgical scissors, reusable
One Step Dilator, 21/22 Fr.
Karl Storz GmbH & Co. KG
27830AC
In Commercial Distribution

  • 04048551090503 ()


  • Fascial tissue dilator, reusable
One Step Dilator for MIP M
Karl Storz GmbH & Co. KG
27830AB
In Commercial Distribution

  • 04048551090480 ()


  • Fascial tissue dilator, reusable
Siemens Biograph mCT one piece couchtop
MEDTEC, INC.
MTIL6029
In Commercial Distribution

  • 00841439114278 ()
MTIL6029

  • Indexed-immobilization patient positioning system
FujiFilm FCT Embrace one piece couchtop
MEDTEC, INC.
MTIL6920
In Commercial Distribution

  • 00841439112793 ()
MTIL6920

  • Indexed-immobilization patient positioning system
One piece couchtop with Lok-Bar™
MEDTEC, INC.
MTIL6720
In Commercial Distribution

  • 00841439106488 ()
MTIL6720

  • Indexed-immobilization patient positioning system
Siemens Definition CT one piece couchtop
MEDTEC, INC.
MTIL6026
In Commercial Distribution

  • 00841439105337 ()
MTIL6026

  • Indexed-immobilization patient positioning system
Siemens Definition CT one piece couchtop
MEDTEC, INC.
MTIL6024
In Commercial Distribution

  • 00841439105320 ()
MTIL6024

  • Indexed-immobilization patient positioning system
One pedal footswitch IP X8 Equipment
Erbe Elektromedizin GmbH
20711-009
In Commercial Distribution

  • 04050147008687 ()
20711-009

  • Foot-switch, electrical
Femoral Spacer Block - One Side -10mm
B-ONE ORTHO, CORP.
8829P00021
In Commercial Distribution

  • 00843575112385 ()
8829P00021

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -9mm
B-ONE ORTHO, CORP.
8829P00020
In Commercial Distribution

  • 00843575112378 ()
8829P00020

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -25mm
B-ONE ORTHO, CORP.
8829P00027
In Commercial Distribution

  • 00843575112446 ()
8829P00027

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -22mm
B-ONE ORTHO, CORP.
8829P00026
In Commercial Distribution

  • 00843575112439 ()
8829P00026

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -19mm
B-ONE ORTHO, CORP.
8829P00025
In Commercial Distribution

  • 00843575112422 ()
8829P00025

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -16mm
B-ONE ORTHO, CORP.
8829P00024
In Commercial Distribution

  • 00843575112415 ()
8829P00024

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -13mm
B-ONE ORTHO, CORP.
8829P00023
In Commercial Distribution

  • 00843575112408 ()
8829P00023

  • Orthopaedic implant/instrument assembling device
Femoral Spacer Block - One Side -11mm
B-ONE ORTHO, CORP.
8829P00022
In Commercial Distribution

  • 00843575112392 ()
8829P00022

  • Orthopaedic implant/instrument assembling device
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