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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QUALA PERIOSTEAL SELDIN 23
NATIONAL DISTRIBUTION & CONTRACTING, INC.
QEP23
In Commercial Distribution

  • Q023QEP231 ()
QEP23

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

  • M724CCB7C3LSIZNS ()
CCB7-C3L-SIZ-NS

  • Silicone-block tissue reconstructive material
"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 Menstrual Cup Size 1 (DTC & AMZ)
Cora
10MenstrualCup-S1A
In Commercial Distribution

  • X0037JBZAL ()


  • 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
DBX Putty 1cc
Musculoskeletal Transplant Foundation, Inc.
428010
In Commercial Distribution

  • W4184428010T0473 ()

  • 1 cc volume
428010

  • Bone matrix implant, human-derived
DBX Putty 0.5cc
Musculoskeletal Transplant Foundation, Inc.
428005
In Commercial Distribution

  • W4184428005T0473 ()

  • 0.5 cc volume
428005

  • Bone matrix implant, human-derived
Legacy DBM, 5CC
Musculoskeletal Transplant Foundation, Inc.
420805
In Commercial Distribution

  • W4184420805T0473 ()

  • 1.0 cc volume
420805

  • Bone matrix implant, human-derived
Legacy DBM, 1CC
Musculoskeletal Transplant Foundation, Inc.
420801
In Commercial Distribution

  • W4184420801T0473 ()

  • 1.0 cc volume
420801

  • Bone matrix implant, human-derived
DBX Putty 0.5cc
Musculoskeletal Transplant Foundation, Inc.
228005
In Commercial Distribution

  • W4184228005T0473 ()

  • 0.5 cc volume
228005

  • Bone matrix implant, human-derived
AFT-DS Diverted Tube (7/8-filled)
Musculoskeletal Transplant Foundation, Inc.
227055
In Commercial Distribution

  • W4184227055T0473 ()
227055

  • Bone matrix implant, human-derived
AFT Straight Tube (3/4 Filled)
Musculoskeletal Transplant Foundation, Inc.
227007
In Commercial Distribution

  • W4184227007T0473 ()
227007

  • Bone matrix implant, human-derived
DBX Putty Inject 10cc
Musculoskeletal Transplant Foundation, Inc.
068100
In Commercial Distribution

  • W4184068100T0473 ()

  • 10 cc volume
068100

  • 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, 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 (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
DBX Putty 2.5cc
Musculoskeletal Transplant Foundation, Inc.
428025
In Commercial Distribution

  • W4184428025T0473 ()

  • 2.5 cc volume
428025

  • Bone matrix implant, human-derived
Legacy DBM, 10CC
Musculoskeletal Transplant Foundation, Inc.
420810
In Commercial Distribution

  • W4184420810T0473 ()

  • 1.0 cc volume
420810

  • Bone matrix implant, human-derived
Legacy DBM, 2.5CC
Musculoskeletal Transplant Foundation, Inc.
420802
In Commercial Distribution

  • W4184420802T0473 ()

  • 1.0 cc volume
420802

  • Bone matrix implant, human-derived
Legacy DBM, 0.5cc
Musculoskeletal Transplant Foundation, Inc.
420800
In Commercial Distribution

  • W4184420800T0473 ()

  • 1.0 cc volume
420800

  • Bone matrix implant, human-derived
DBX Putty 2.5cc
Musculoskeletal Transplant Foundation, Inc.
228025
In Commercial Distribution

  • W4184228025T0473 ()

  • 2.5 cc volume
228025

  • Bone matrix implant, human-derived
DBX Putty 1cc
Musculoskeletal Transplant Foundation, Inc.
228010
In Commercial Distribution

  • W4184228010T0473 ()

  • 1 cc volume
228010

  • Bone matrix implant, human-derived
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