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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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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
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
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
STERILE DISPOSABLE EQUIPMENT COVER - C-ARM DRAPE 36" X 90" - 4 POLY STRAPS
PREFERRED MEDICAL PRODUCTS, LLC
C-ARM 90
In Commercial Distribution

  • 10680211000241 ()
  • 00680211000244 ()
C-ARM 90

  • Patient surgical drape, single-use
16.4cm Universal Healing Abutment Forceps Flat-Handle 90' In-Line
LASCHAL SURGICAL INSTRUMENTS, INC
1
In Commercial Distribution

  • B659HAF900 ()
HAF/90

  • Dental implant/prosthesis handling forceps
Barbed Fxp Probe Barbed Probes 90'
LASCHAL SURGICAL INSTRUMENTS, INC
1
In Commercial Distribution

  • B659BFXP900 ()
B-FXP/90

  • Dressing/utility forceps, scissors-like, reusable
No Description
MORIA SA
CBSU 90 HEAD - ART. CHAMBER
In Commercial Distribution

  • 03700483601998 ()
19178/90

  • Microkeratome
M4/AM5 Leadwires w/Banana, no combiner- 90º
GRAPHIC CONTROLS ACQUISITION CORP
LWG-440002910/90
In Commercial Distribution

  • 00009336006311 ()
LWG-440002910/90

  • Electrocardiographic lead set, reusable
Molded 5-Lead Cable,90º
GRAPHIC CONTROLS ACQUISITION CORP
CBG-72540R/90
In Commercial Distribution

  • 00009336005956 ()
CBG-72540R/90

  • Patient monitoring system module, electrocardiographic
LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
Not in Commercial Distribution

  • 03664539002262 ()

  • Length: 90 Centimeter
PCP-18A/90

  • Depth electrode
LENGTH 90CM, CONNECTION OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
EXTENSION CABLE
In Commercial Distribution

  • 03664539002217 ()

  • Length: 90 Centimeter
PCP-18/90

  • Depth electrode
Femoral PS Box Guide, Size 9
WALDEMAR LINK GmbH & Co. KG
881-113/90
In Commercial Distribution

  • 04026575305643 ()
881-113/90

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Femoral Cutting Block, CCK, 4-in-1 Cut, Size 9
WALDEMAR LINK GmbH & Co. KG
881-115/90
In Commercial Distribution

  • 04026575305360 ()
881-115/90

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Femoral Cutting Block, 4-in-1 Cut, Size 9
WALDEMAR LINK GmbH & Co. KG
881-119/90
In Commercial Distribution

  • 04026575305162 ()
881-119/90

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Tibial Component, Modular
WALDEMAR LINK GmbH & Co. KG
880-100/90
In Commercial Distribution

  • 04026575251568 ()
880-100/90

  • Coated knee tibia prosthesis
Femoral Component, CCK
WALDEMAR LINK GmbH & Co. KG
880-030/90
In Commercial Distribution

  • 04026575248636 ()
880-030/90

  • Uncoated knee femur prosthesis, metallic
Femoral Component, PS
WALDEMAR LINK GmbH & Co. KG
880-021/90
In Commercial Distribution

  • 04026575248506 ()
880-021/90

  • Uncoated knee femur prosthesis, metallic
Femoral Component, PS
WALDEMAR LINK GmbH & Co. KG
880-020/90
In Commercial Distribution

  • 04026575248193 ()
880-020/90

  • Uncoated knee femur prosthesis, metallic
Femoral Component, CR
WALDEMAR LINK GmbH & Co. KG
880-011/90
In Commercial Distribution

  • 04026575247721 ()
880-011/90

  • Uncoated knee femur prosthesis, metallic
Tibial Component, Monoblock
WALDEMAR LINK GmbH & Co. KG
880-090/90
In Commercial Distribution

  • 04026575251223 ()
880-090/90

  • Coated knee tibia prosthesis
Femoral Component, CCK
WALDEMAR LINK GmbH & Co. KG
880-081/90
In Commercial Distribution

  • 04026575250615 ()
880-081/90

  • Coated knee femur prosthesis
Femoral Component, CCK
WALDEMAR LINK GmbH & Co. KG
880-080/90
In Commercial Distribution

  • 04026575250424 ()
880-080/90

  • Coated knee femur prosthesis
Femoral Component, PS
WALDEMAR LINK GmbH & Co. KG
880-071/90
In Commercial Distribution

  • 04026575250240 ()
880-071/90

  • Coated knee femur prosthesis
Femoral Component, PS
WALDEMAR LINK GmbH & Co. KG
880-070/90
In Commercial Distribution

  • 04026575249589 ()
880-070/90

  • Coated knee femur prosthesis
Femoral Component, CR
WALDEMAR LINK GmbH & Co. KG
880-061/90
In Commercial Distribution

  • 04026575249459 ()
880-061/90

  • Coated knee femur prosthesis
Femoral Component, CR
WALDEMAR LINK GmbH & Co. KG
880-060/90
In Commercial Distribution

  • 04026575249213 ()
880-060/90

  • Coated knee femur prosthesis
Tibial Component, Modular
WALDEMAR LINK GmbH & Co. KG
880-050/90
In Commercial Distribution

  • 04026575248971 ()
880-050/90

  • Uncoated knee tibia prosthesis, metallic
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