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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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Mono Screw A type (Single) 7.5 x 90mm
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809319780595 ()

  • Length: 90 Millimeter
  • Diameter 7.5mm
FX.MS.7590

  • Bone-screw internal spinal fixation system, non-sterile
Co Ease Cohesive Bandage 3" x 5 yds. MULTI-COLOR LF
Hemasource, Inc.
CE30LFC
In Commercial Distribution

  • 10857425005144 ()
  • 00857425005147 ()
  • 20857425005141 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 1.5" x 5 yds. LF. TAN
Hemasource, Inc.
CE15LF
In Commercial Distribution

  • 10857425005113 ()
  • 00857425005116 ()
  • 20857425005110 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 6" x 5 yds. LF. TAN
Hemasource, Inc.
CE60LF
In Commercial Distribution

  • 10857425005106 ()
  • 00857425005109 ()
  • 20857425005103 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 4" x 5 yds. LF. TAN
Hemasource, Inc.
CE40LF
In Commercial Distribution

  • 10857425005090 ()
  • 00857425005093 ()
  • 20857425005097 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 3" x 5 yds. LF. TAN
Hemasource, Inc.
CE30LF
In Commercial Distribution

  • 10857425005083 ()
  • 00857425005086 ()
  • 20857425005080 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 2" x 5 yds. LF. TAN
Hemasource, Inc.
CE20LF
In Commercial Distribution

  • 10857425005076 ()
  • 00857425005079 ()
  • 20857425005073 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 1" x 5 yds. LF. TAN.
Hemasource, Inc.
CE10LF
In Commercial Distribution

  • 10857425005069 ()
  • 00857425005062 ()
  • 20857425005066 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 6" x 5 yds. TAN. STERILE
Hemasource, Inc.
CE60LFS
In Commercial Distribution

  • 10857425005052 ()
  • 00857425005055 ()
  • 20857425005059 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 4" x 5 yds. TAN. STERILE
Hemasource, Inc.
CE40LFS
In Commercial Distribution

  • 10857425005045 ()
  • 00857425005048 ()
  • 20857425005042 ()


  • Non-adhesive device retention bandage
Co Ease Cohesive Bandage 3" x 5 yds. TAN. STERILE
Hemasource, Inc.
CE30LFS
In Commercial Distribution

  • 10857425005038 ()
  • 00857425005031 ()
  • 20857425005035 ()


  • Non-adhesive device retention bandage
LP35,EN-US,MAS-SP/CO,MED-CO2,SUN-NIBP,IP-TEMP,12L,WIFI/CELL
PHYSIO-CONTROL, INC.
99335
In Commercial Distribution

  • 00883873765661 ()
99335-000029

  • Physiologic-monitoring defibrillation system
COLPAC FREEZER, C/W 12 STD. CO LPACS US STD
DJO, LLC
90910
In Commercial Distribution

  • 00888912042970 ()


  • Cold therapy pack chilling unit
MAGNUM CERAMIC Co - Cylinder 5 PLS - 1Kg - Jar1 - NLM - MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612201014 ()


  • Dental casting non-noble alloy
MAGNUM CERAMIC Co - Cylinder 5 PLS - 1kg - Box1 - LM – MD
MESA DI SALA GIACOMO & C. SNC
1
In Commercial Distribution

  • 08050612200987 ()


  • Dental casting non-noble alloy
Interface for Connecting Merck & Co., Inc./MSD Neuromuscular Transmission Monitor
NIHON KOHDEN CORPORATION
QF-909P
In Commercial Distribution

  • 04931921104118 ()
QF-909P

  • General-purpose multi-parameter bedside monitor
Interface for Connecting Merck & Co., Inc./MSD Neuromuscular Transmission Monitor
NIHON KOHDEN AMERICA, INC.
QF-909P
In Commercial Distribution

  • 00841983102578 ()
QF-909P

  • General-purpose multi-parameter bedside monitor
Billeau Ear Loop Size 2, 3mm x 5mm wire loop
ELMED INCORPORATED
63-310202
In Commercial Distribution

  • 00842180169852 ()
63-310202

  • ENT surgical procedure kit, non-medicated, reusable
COVER BACK TABLE_50"X 90"_SMS_non-sterile_300EA/CS
GRI Medical & Electronic Technology Co., Ltd.
8065-1538-99-Sample
In Commercial Distribution

  • 06931918115514 ()
  • 16931918115511 ()


  • Patient surgical drape, single-use
Earlens Fitting Software, Wireless Application Identifier (8012) contains the software version Lot Number is the packaging lot number
EARLENS CORPORATION
ELFW01
Not in Commercial Distribution

  • 08500130070192 ()
ELFW01

  • Audiometric/hearing device software
Screw T6 Torx 2mm X 5mm Model Number 241-04B Screw T6 Torx 2mm X 6mm Model Number 241-04C
Neurovention LLC
241-04
In Commercial Distribution

  • G28424104 ()


  • Craniofacial bone screw, non-bioabsorbable
Orion Trial Neck, High Offset, Size 8-9 (Version or Model Number) Has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122208
In Commercial Distribution

  • M716101222080 ()
101-222-6252

  • Femoral stem prosthesis trial
Orion Trial Neck, High Offset, Size 2-3 (Version or Model Number) has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122202
In Commercial Distribution

  • M716101222020 ()
111-19-6262

  • Femoral stem prosthesis trial
Orion Trial Neck, High Offset, Size 0-1 (Version or Model Number) Has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122200
In Commercial Distribution

  • M716101222000 ()
111-19-6261

  • Femoral stem prosthesis trial
Orion Trial Neck, Standard Offset, Size 10-12 (Version or Model Number) has been changed to the Catalog number.
ORTHOMEDFLEX LLC
10122110
In Commercial Distribution

  • M716101221100 ()
111-19-6256

  • Femoral stem prosthesis trial
Orion Trial Neck, Standard Offset, Size 8-9 (Version or Model Number) has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122108
In Commercial Distribution

  • M716101221080 ()
111-19-6255

  • Femoral stem prosthesis trial
Orion Trial Neck, Standard Offset, Size 6-7 (Version or Model Number) Has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122106
In Commercial Distribution

  • M716101221060 ()
101-221-06

  • Femoral stem prosthesis trial
Orion Trial Neck, Standard Offset, Size 4-5 (Version or Model Number) has been changed to the catalog number.
ORTHOMEDFLEX LLC
10122104
In Commercial Distribution

  • M716101221040 ()
111-19-6253

  • Femoral stem prosthesis trial
Orion Trial Neck, Standard Offset, Size 0-1 (Version or Model Number) has been changed to the Catalog number.
ORTHOMEDFLEX LLC
10122100
In Commercial Distribution

  • M716101221000 ()
111-19-6251

  • Femoral stem prosthesis trial
FIZE kUO Disposable Kit Catalog number for 1 pc: FI-KT00-KU01-0001 Catalog number for 10 pcs in box: FI-FG00-KU03-0001
FIZE RESEARCH LTD
G1
In Commercial Distribution

  • 17290019239243 ()
  • 07290019239246 ()
  • 07290019239093 ()
FI-KT00-KU01-0001

  • Urine monitoring system
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