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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Calf Implant Sizer
IMPLANTECH ASSOCIATES, INC.
Carlsen Style / Size C3L
In Commercial Distribution

  • M724CCB7C3LSIZNS ()
CCB7-C3L-SIZ-NS

  • Silicone-block tissue reconstructive material
18.5" Bayonet Cup Curette #4 Str. Up Cup Teeth Custom Handle
Life Instrument Corporation
714-1804-0UT-1
In Commercial Distribution

  • M93071418040UT10 ()


  • Bone curette, reusable
RECL DLX CL CR D-AMR STEEL BLUE
GF HEALTH PRODUCTS, INC.
IN566DG9214
In Commercial Distribution

  • M368IN566DG92141 ()


  • Reclining chair
EXAM TABLE/3-PASS DRAWER
GF HEALTH PRODUCTS, INC.
420-WG
In Commercial Distribution

  • M368420WG1 ()


  • Examination/treatment table, manual
DBM Putty, 0.5cc
Musculoskeletal Transplant Foundation, Inc.
030005
In Commercial Distribution

  • W4184030005T0473 ()

  • 0.5 cc volume
030005

  • Bone matrix implant, human-derived
DBX Paste, 10cc
Musculoskeletal Transplant Foundation, Inc.
028100
In Commercial Distribution

  • W4184028100T0476 ()

  • 10 cc volume
028100

  • Bone matrix implant, human-derived
DBX Paste, 5cc
Musculoskeletal Transplant Foundation, Inc.
028050
In Commercial Distribution

  • W4184028050T0476 ()

  • 5 cc volume
028050

  • Bone matrix implant, human-derived
DBX Paste, 1cc
Musculoskeletal Transplant Foundation, Inc.
028010
In Commercial Distribution

  • W4184028010T0476 ()

  • 1.0 cc volume
028010

  • Bone matrix implant, human-derived
DBX Paste, 0.5cc
Musculoskeletal Transplant Foundation, Inc.
028005
In Commercial Distribution

  • W4184028005T0476 ()
028005

  • Bone matrix implant, human-derived
Calcium compound bone void filler with DBM (10 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
10 cc
In Commercial Distribution

  • W4146EB0010T0475 ()
130703-10

  • Cadaveric-donor/synthetic mineral bone graft
Calcium compound bone void filler with DBM (5cc), Previously sold under Trabexus® EB brand name.
Vivorte, Inc
5 cc
In Commercial Distribution

  • W4146EB0005T0475 ()
130703-05

  • Cadaveric-donor/synthetic mineral bone graft
Calcium compound bone void filler with DBM (3 cc), previously sold under Trabexus® EB brand name.
Vivorte, Inc
3 cc
In Commercial Distribution

  • W4146EB0003T0475 ()
130703-03

  • Cadaveric-donor/synthetic mineral bone graft
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) 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
QUALA PERIOSTEAL SELDIN 23
NATIONAL DISTRIBUTION & CONTRACTING, INC.
QEP23
In Commercial Distribution

  • Q023QEP231 ()
QEP23

  • Periosteal elevator, reusable
"Soft Fit Disc"
Cora
10Disc-200
In Commercial Distribution

  • X003852LQL ()


  • Menstrual cup, non-latex, reusable
Cora Menstrual Cup Size 2 (DTC & AMZ)
Cora
10MenstrualCup-S2A
In Commercial Distribution

  • X0037JJ66L ()


  • Menstrual cup, non-latex, reusable
Cora Disc, DTC + Amazon
Cora
10Disc-008
Not in Commercial Distribution

  • X0037EZAVV ()


  • Menstrual cup, non-latex, reusable
Disc, Amazon in Tins
Cora
10Disc-003
Not in Commercial Distribution

  • X002US3067 ()


  • Menstrual cup, non-latex, reusable
QuickGraft Pre-Sutured Tendon
Musculoskeletal Transplant Foundation, Inc.
430PST
In Commercial Distribution

  • W41844300PSTT165 ()
430PST

  • Tendon graft
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