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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No Description
Unique Surgical
Femoral
In Commercial Distribution

  • 00854515008002 ()


  • Orthopaedic implant impactor, reusable
Femoral Calcar Planer
Shalby Advanced Technologies, Inc.
1800-1-1100
In Commercial Distribution

  • 00840286841955 ()

  • Femoral Calcar Planer
1800-1-1100

  • Bone file/rasp, manual, reusable
Femoral Head Impactor, UniSyn
Shalby Advanced Technologies, Inc.
4410-20070-A
In Commercial Distribution

  • 00840286840989 ()

  • Femoral Head Impactor
4410-20070-A

  • Orthopaedic implant impactor, reusable
Distal Femoral Sizer
Shalby Advanced Technologies, Inc.
2800-1-1050
In Commercial Distribution

  • 00840286845335 ()

  • Distal Femoral Sizer
2800-1-1050

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Exactech, Inc.
02-010-66-3003
In Commercial Distribution

  • 10885862310873 ()

  • Height: 52 Millimeter
  • Femoral size: Large
02-010-66-3003

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-3002
In Commercial Distribution

  • 10885862310866 ()

  • Femoral size: Large
  • Height: 42 Millimeter
02-010-66-3002

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-3001
In Commercial Distribution

  • 10885862310859 ()

  • Height: 32 Millimeter
  • Femoral size: Large
02-010-66-3001

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-2003
In Commercial Distribution

  • 10885862310842 ()

  • Femoral size: Medium
  • Height: 52 Millimeter
02-010-66-2003

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-2002
In Commercial Distribution

  • 10885862310835 ()

  • Height: 42 Millimeter
  • Femoral size: Medium
02-010-66-2002

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-2001
In Commercial Distribution

  • 10885862310828 ()

  • Femoral size: Medium
  • Height: 32 Millimeter
02-010-66-2001

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-1003
In Commercial Distribution

  • 10885862310811 ()

  • Height: 52 Millimeter
  • Femoral size: Small
02-010-66-1003

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-1002
In Commercial Distribution

  • 10885862310804 ()

  • Femoral size: Small
  • Height: 42 Millimeter
02-010-66-1002

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-1001
In Commercial Distribution

  • 10885862310798 ()

  • Height: 32 Millimeter
  • Femoral size: Small
02-010-66-1001

  • Sleeve femoral/tibial extension, coated
Consensus, Femoral Impactor/Extractor, Assembly
Shalby Advanced Technologies, Inc.
2800-0-2950
In Commercial Distribution

  • 00840286845182 ()

  • Femoral Impactor/Extractor, Assembly
2800-0-2950

  • Orthopaedic implant impactor, reusable
  • Orthopaedic inorganic implant inserter/extractor, reusable
RKS, Assembly, Femoral Alignment Guide
Shalby Advanced Technologies, Inc.
2970-0-0021
In Commercial Distribution

  • 00840286842075 ()

  • Assembly, Femoral Alignment Guide
2970-0-0021

  • Orthopaedic prosthesis implantation positioning instrument, reusable
Femoral/Tibial Impactor Handle
Shalby Advanced Technologies, Inc.
2800-0-0700
In Commercial Distribution

  • 00840286855075 ()

  • Femoral/Tibial Impactor Handle
2800-0-0700

  • Surgical instrument handle, non-torque-limiting
No Description
Exactech, Inc.
02-010-66-4003
In Commercial Distribution

  • 10885862310903 ()

  • Femoral size: Extra Large
  • Height: 52 Millimeter
02-010-66-4003

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-4002
In Commercial Distribution

  • 10885862310897 ()

  • Height: 42 Millimeter
  • Femoral size: Extra Large
02-010-66-4002

  • Sleeve femoral/tibial extension, coated
No Description
Exactech, Inc.
02-010-66-4001
In Commercial Distribution

  • 10885862310880 ()

  • Femoral size: Extra Large
  • Height: 32 Millimeter
02-010-66-4001

  • Sleeve femoral/tibial extension, coated
DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS OR FOR SALE Asymmetric, Femoral/Tibia 58, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
881501
In Commercial Distribution

  • 15060155712793 ()

  • Asymmetric, Femoral/Tibia 58
881501

  • Orthopaedic cement spacer
DEMONSTRATIVE USE ONLY. NOT FOR USE IN PATIENTS NOT FOR SALE Asymmetric, Femoral/Tibia 65, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
881500
In Commercial Distribution

  • 15060155712786 ()

  • Asymmetric, Femoral/Tibia 65
881500

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 79, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885445
In Commercial Distribution

  • 15060155712199 ()

  • Asymmetric, Femoral/Tibia 79
885445

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 79, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885444
In Commercial Distribution

  • 15060155712182 ()

  • Asymmetric, Femoral/Tibia 79
885444

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 72, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885443
In Commercial Distribution

  • 15060155712175 ()

  • Asymmetric, Femoral/Tibia 72
885443

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 72, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885442
In Commercial Distribution

  • 15060155712168 ()

  • Asymmetric, Femoral/Tibia 72
885442

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 58, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885441
In Commercial Distribution

  • 15060155712151 ()

  • Asymmetric, Femoral/Tibia 58
885441

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 65, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885440
In Commercial Distribution

  • 15060155712144 ()

  • Asymmetric, Femoral/Tibia 65
885440

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 58, Left Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885439
In Commercial Distribution

  • 15060155712137 ()

  • Asymmetric, Femoral/Tibia 58
885439

  • Orthopaedic cement spacer
Asymmetric, Femoral/Tibia 58, Right Knee Spacer with gentamicin is a temporary implant whose main function is to preserve the articular space during a 2 Stage Revision Arthroplasty. Aids in the treatment of infection that emerged due to the implant of knee prosthesis. Once the patient has finished the specific treatment & no signs of the infection remain, the spacer is removed to be replaced by a definitive new prosthesis. This is a prolonged use implant (maximum intended use period of 180 days)
BIOCOMPOSITES LTD
885438
In Commercial Distribution

  • 15060155712120 ()

  • Asymmetric, Femoral/Tibia 58
885438

  • Orthopaedic cement spacer
FEMORAL
Cardinal Health 200, LLC
SANOCFEV12
In Commercial Distribution

  • 50888439877456 ()
  • 10888439877458 ()
SANOCFEV12

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SAN18FMTV7
In Commercial Distribution

  • 50888439327555 ()
  • 10888439327557 ()
SAN18FMTV7

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEV15
In Commercial Distribution

  • 50888439982334 ()
  • 10888439982336 ()
SANOCFEV15

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEVH6
In Commercial Distribution

  • 50888439419670 ()
  • 10888439419672 ()
SANOCFEVH6

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEVH8
In Commercial Distribution

  • 50888439523902 ()
  • 10888439523904 ()
SANOCFEVH8

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEVH7
In Commercial Distribution

  • 50888439476444 ()
  • 10888439476446 ()
SANOCFEVH7

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEVH5
In Commercial Distribution

  • 50888439360101 ()
  • 10888439360103 ()
SANOCFEVH5

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEV11
In Commercial Distribution

  • 50888439811436 ()
  • 10888439811438 ()
SANOCFEV11

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEV10
In Commercial Distribution

  • 50888439796252 ()
  • 10888439796254 ()
SANOCFEV10

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEVH9
In Commercial Distribution

  • 50888439695074 ()
  • 10888439695076 ()
SANOCFEVH9

  • Angiography kit
FEMORAL
Cardinal Health 200, LLC
SANOCFEV13
In Commercial Distribution

  • 50888439935996 ()
  • 10888439935998 ()
SANOCFEV13

  • Angiography kit
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