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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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Origin NS Stem Broach - 09348215087302

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6010
In Commercial Distribution

  • 09348215087302 ()


  • Orthopaedic broach

Origin NS Stem Broach - 09348215087296

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-23-6000
In Commercial Distribution

  • 09348215087296 ()


  • Orthopaedic broach

Origin Short Trial Neck - 09348215081416

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-182-026
In Commercial Distribution

  • 09348215081416 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080150

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2006
In Commercial Distribution

  • 09348215080150 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080143

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2005
In Commercial Distribution

  • 09348215080143 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080136

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2004
In Commercial Distribution

  • 09348215080136 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080129

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2003
In Commercial Distribution

  • 09348215080129 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080112

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2002
In Commercial Distribution

  • 09348215080112 ()


  • Surgical implant template, reusable

Origin DAA Trial Neck - 09348215080105

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
111-39-2001
In Commercial Distribution

  • 09348215080105 ()


  • Surgical implant template, reusable

Origin Size 18 Template - 09348215074807

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-118
In Commercial Distribution

  • 09348215074807 ()


  • Surgical implant template, reusable

Origin Size 16 Template - 09348215074791

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-116
In Commercial Distribution

  • 09348215074791 ()


  • Surgical implant template, reusable

Origin Size 15 Template - 09348215074784

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-115
In Commercial Distribution

  • 09348215074784 ()


  • Surgical implant template, reusable

Origin Size 14 Template - 09348215074777

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-114
In Commercial Distribution

  • 09348215074777 ()


  • Surgical implant template, reusable

Origin Size 13 Template - 09348215074760

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-113
In Commercial Distribution

  • 09348215074760 ()


  • Surgical implant template, reusable

Origin Size 12 Template - 09348215074753

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-112
In Commercial Distribution

  • 09348215074753 ()


  • Surgical implant template, reusable

Origin Size 11 Template - 09348215074746

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-111
In Commercial Distribution

  • 09348215074746 ()


  • Surgical implant template, reusable

Origin Size 10 Template - 09348215074739

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-110
In Commercial Distribution

  • 09348215074739 ()


  • Surgical implant template, reusable

Origin Size 9 Template - 09348215074722

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-109
In Commercial Distribution

  • 09348215074722 ()


  • Surgical implant template, reusable

Origin Size 8 Template - 09348215074715

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-108
In Commercial Distribution

  • 09348215074715 ()


  • Surgical implant template, reusable

DJO Origin Instrument Tray - 09348215058098

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-212-409
In Commercial Distribution

  • 09348215058098 ()


  • Instrument tray, reusable

Super Tray inner - Origin - 09348215039905

No Description
SIGNATURE ORTHOPAEDICS PTY LTD
112-36-0004
In Commercial Distribution

  • 09348215039905 ()


  • Instrument tray, reusable

Epicel (cultured epidermal autografts) - W41020AU201S1969

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures a minimum of 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
N/A
In Commercial Distribution

  • W41020AU201S1969 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft

Epicel (cultured epidermal autografts) - W41020AU201P0001

Epicel (cultured epidermal autografts) is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area. Epicel is authorized by Federal law for use in adult and pediatric patients who have deep dermal or full-thickness burns comprising a total body surface area greater than or equal to 30%. Epicel may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
VERICEL CORPORATION
0
In Commercial Distribution

  • W41020AU201P0001 ()

  • Area/Surface Area: 50 Square centimeter


  • Cultured skin autograft/xenograft

PRIMO - 00840216117952

60" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB60MBNB
In Commercial Distribution

  • 00840216117952 ()


  • Gait rehabilitation system harness

PRIMO - 00840216117945

60" Gait Belt, Metal Buckle, Natural
Asp Global, LLC
GB60MBN
In Commercial Distribution

  • 00840216117945 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114067

72" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB72QRP
In Commercial Distribution

  • 00840216114067 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114050

72" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB72QRNRB
In Commercial Distribution

  • 00840216114050 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114043

72" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB72QRNB
In Commercial Distribution

  • 00840216114043 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114029

72" Gait Belt, Metal Buckle, Pastel
Asp Global, LLC
GB72MBP
In Commercial Distribution

  • 00840216114029 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114012

72" Gait Belt, Metal Buckle, Navy Blue
Asp Global, LLC
GB72MBNB
In Commercial Distribution

  • 00840216114012 ()


  • Gait rehabilitation system harness

PRIMO - 00840216114005

60" Gait Belt, Quick Release Buckle, Pastel
Asp Global, LLC
GB60QRP
In Commercial Distribution

  • 00840216114005 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113992

60" Gait Belt, Quick Release Buckle, Navy Blue
Asp Global, LLC
GB60QRNB
In Commercial Distribution

  • 00840216113992 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113985

60" Gait Belt, Quick Release Buckle, Natural
Asp Global, LLC
GB60QRN
In Commercial Distribution

  • 00840216113985 ()


  • Gait rehabilitation system harness

PRIMO - 00840216113978

60" Gait Belt, Quick Release Buckle, Natural w/ Red & Blue Stripe
Asp Global, LLC
GB60QRNRB
In Commercial Distribution

  • 00840216113978 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107052

BELT, QUICK CLEAN GAIT, PINK, 36", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM36PK
In Commercial Distribution

  • 00840216107052 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107045

BELT, QUICK CLEAN GAIT, BLUE, 60", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM60BL
In Commercial Distribution

  • 00840216107045 ()


  • Gait rehabilitation system harness

PRIMO - 00840216107038

BELT, QUICK CLEAN GAIT, BLACK, 72", METAL BUCKLE WITH CLAMP, EASY TO CLEAN LAMINATED 2" WEBBING, LATEX-FREE, 1EA/BG, 40BG/CS
Asp Global, LLC
GBARQM72BK
In Commercial Distribution

  • 00840216107038 ()


  • Gait rehabilitation system harness

PRIMO - 00840216105737

BELT GAIT NATURAL STRIPES WITH BLUE & RED 54"
Asp Global, LLC
GBANS54
In Commercial Distribution

  • 00840216105737 ()


  • Gait rehabilitation system harness

PRIMO/ASP MEDICAL - 00840216100138

72" GAIT BELT - NATURAL, 1/EA
Asp Global, LLC
GB72MBN
In Commercial Distribution

  • 00840216100138 ()


  • Gait rehabilitation system harness

NA - 03664539003917

GUIDE FOR Ø 2.45MM ACCESSORIES ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
INSTRUMENT GUIDE
In Commercial Distribution

  • 03664539003917 ()
ACS-789/120R

  • Depth electrode
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