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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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GalaFLEX 3D - 00810054980452

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-26
In Commercial Distribution

  • 00810054980452 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980445

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-25
In Commercial Distribution

  • 00810054980445 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CESH05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980438

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-24
In Commercial Distribution

  • 00810054980438 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980421

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-23
In Commercial Distribution

  • 00810054980421 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CESH03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980414

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-22
In Commercial Distribution

  • 00810054980414 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3D - 00810054980407

GalaFLEX 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100042-21
In Commercial Distribution

  • 00810054980407 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CESH01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980254

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-34
In Commercial Distribution

  • 00810054980254 ()

  • Outer Diameter: 7.6 Centimeter
CEFR14

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980247

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-33
In Commercial Distribution

  • 00810054980247 ()

  • Outer Diameter: 7.6 Centimeter
CEFR13

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980230

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-32
In Commercial Distribution

  • 00810054980230 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR12

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980223

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-31
In Commercial Distribution

  • 00810054980223 ()

  • Width: 10.2 Centimeter
  • Height: 2.5 Centimeter
CEFR11

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980216

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-30
In Commercial Distribution

  • 00810054980216 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR10

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980209

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-29
In Commercial Distribution

  • 00810054980209 ()

  • Width: 7.6 Centimeter
  • Height: 2.5 Centimeter
CEFR09

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980193

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-27
In Commercial Distribution

  • 00810054980193 ()

  • Width: 20.3 Centimeter
  • Height: 7.6 Centimeter
CEFR07

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980186

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-26
In Commercial Distribution

  • 00810054980186 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CEFR06

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980179

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-25
In Commercial Distribution

  • 00810054980179 ()

  • Width: 21.0 Centimeter
  • Height: 7.5 Centimeter
CEFR05

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980162

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-24
In Commercial Distribution

  • 00810054980162 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CEFR04

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980155

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-23
In Commercial Distribution

  • 00810054980155 ()

  • Width: 18.5 Centimeter
  • Height: 6.4 Centimeter
CEFR03

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980148

GalaFLEX 3DR scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-22
In Commercial Distribution

  • 00810054980148 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR02

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GalaFLEX 3DR - 00810054980131

GalaFORM 3D scaffold is a single layer bioresorbable surgical mesh made from poly 4 hydroxybutyrate (P4HB). P4HB is produced from a naturally occurring monomer and is processed into monofilament fibers and knitted into a surgical scaffold.
Tepha, Inc.
100043-21
In Commercial Distribution

  • 00810054980131 ()

  • Width: 15.5 Centimeter
  • Height: 5.3 Centimeter
CEFR01

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

test - 25420045506951

test
Hologic, Inc.
test
In Commercial Distribution

  • 25420045506951 ()


  • Radiological breast positioner, non-wearable

A Plus - 00683534060148

LAB COAT E/W, POCKETS;WHITE, XXL BULK, 25/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534060144 ()
  • 00683534060148 ()
68-561W-Y

  • Isolation gown, single-use

A Plus - 00683534060131

LAB COAT E/W, POCKETS;WHITE, XL BULK, 25/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534060137 ()
  • 00683534060131 ()
68-561W-X

  • Isolation gown, single-use

A Plus - 00683534060117

PULLOVER SHIRT E/W;WHITE, XXL, 25/BG, 50/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534060113 ()
  • 00683534060117 ()
68-551W-Y

  • Isolation gown, single-use

A Plus - 00683534060070

MAX CONTROL GOWN, E/W;XL, F/B, 10/BG, 50/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534060076 ()
  • 00683534060070 ()
68-531W-X

  • Isolation gown, single-use

A Plus - 00683534060063

MAX CONTROL GOWN, E/W;L, F/B, 10/BG, 50/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534060069 ()
  • 00683534060063 ()
68-531W-L

  • Isolation gown, single-use

A Plus - 00683534060032

ISOLATION GOWN E/W ,W/T;YELLOW, U, 10/BG, 50/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534060038 ()
  • 00683534060032 ()
68-501Y-U

  • Isolation gown, single-use

A Plus - 00683534060025

ISOLATION GOWN, White, Universal,10/BG, 50/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534060021 ()
  • 00683534060025 ()
68-501W-U

  • Isolation gown, single-use

A Plus - 00683534040058

BAND BAG, 36"X30", 50PCS/LINER, 200PCS/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534040054 ()
  • 00683534040058 ()
BG-3630-2T

  • Medical equipment/instrument drape, single-use

A Plus - 00683534040041

BAND BAG, 36"X20", 50PCS/LINER, 200PCS/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534040047 ()
  • 00683534040041 ()
BG-3620-2T

  • Medical equipment/instrument drape, single-use

A Plus - 00683534040034

3M Hot Cold Pack - #1572 Spunbond Polypropylene Cover, 100/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534040030 ()
  • 00683534040034 ()
70-2004-4277-3

  • Hot/cold therapy pack, single-use

A Plus - 00683534040027

3M Hot Cold Pack - Spunbond Polypropylene Cover (Tri-Fold), Bulk, 2000 PCS/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534040023 ()
  • 00683534040027 ()
44-0040-8719-1

  • Hot/cold therapy pack, single-use

A Plus - 00683534040010

3M Hot Cold Pack - Nylon Cover, Bulk, 1000 PCS/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534040016 ()
  • 00683534040010 ()
44-0040-8718-3

  • Hot/cold therapy pack, single-use

A Plus - 00683534010266

BOUFFANT CAP, 24";BLUE, 100/BX, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 70683534010265 ()
  • 00683534010266 ()
  • 80683534010262 ()
68-324B-N

  • Surgical cap, single-use

A Plus - 00683534010259

BOUFFANT CAP, 21";WHITE, 100/BX, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 70683534010258 ()
  • 00683534010259 ()
  • 80683534010255 ()
68-321W-N

  • Surgical cap, single-use

A Plus - 00683534010242

HAIRNET REG 24", L/W, WH;144 PCS/BG, 10 BG/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010248 ()
  • 00683534010242 ()
68-403W-G

  • Surgical cap, single-use

A Plus - 00683534010235

BOUFFANT CAP, Green, 24" 100/BX, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 70683534010234 ()
  • 00683534010235 ()
  • 80683534010231 ()
68-324G-N

  • Surgical cap, single-use

A Plus - 00683534010228

BOUFFANT CAP, 24" BLUE;100/BG, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010224 ()
  • 00683534010228 ()
68-324B-PC

  • Surgical cap, single-use

A Plus - 00683534010198

BOUFFANT CAP 21" WHT,;100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010194 ()
  • 00683534010198 ()
68-321W-K

  • Surgical cap, single-use

A Plus - 00683534010181

BOUFFANT CAP, 21" GREEN;100/BG, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010187 ()
  • 00683534010181 ()
68-321G-PC

  • Surgical cap, single-use

A Plus - 00683534010174

BOUFFANT CAP 21"; GREEN, 100/BX, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010170 ()
  • 00683534010174 ()
68-321G-N

  • Surgical cap, single-use

A Plus - 00683534010167

BOUFFANT CAP 21";GREEN, 100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010163 ()
  • 00683534010167 ()
68-321G-K

  • Surgical cap, single-use

A Plus - 00683534010150

BOUFFANT CAP, 21";BLUE, 100/BX, 500/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010156 ()
  • 00683534010150 ()
68-321B-N

  • Surgical cap, single-use

A Plus - 00683534010143

BOUFFANT CAP, 21";BLUE, 100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010149 ()
  • 00683534010143 ()
68-321B-K

  • Surgical cap, single-use

A Plus - 00683534010136

HAIRNET 28" HW;WHITE, 100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010132 ()
  • 00683534010136 ()
68-414W-K

  • Surgical cap, single-use

A Plus - 00683534010129

HAIRNET 24" HW;WHITE, 100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010125 ()
  • 00683534010129 ()
68-413W-K

  • Surgical cap, single-use

A Plus - 00683534010112

HAIRNET 21" HW;WHITE, 100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010118 ()
  • 00683534010112 ()
68-412W-K

  • Surgical cap, single-use

A Plus - 00683534010105

HAIRNET 18" HW;WHITE, 100/BG, 1000/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010101 ()
  • 00683534010105 ()
68-411W-K

  • Surgical cap, single-use

A Plus - 00683534010099

HAIRNET REG 28", L/W, WH;144 PCS/BG, 10 BG/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010095 ()
  • 00683534010099 ()
68-404W-G

  • Surgical cap, single-use

A Plus - 00683534010075

HAIRNET REG 21", L/W, WH;144 PCS/BG, 10 BG/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010071 ()
  • 00683534010075 ()
68-402W-G

  • Surgical cap, single-use

A Plus - 00683534010068

HAIRNET REG 18", L/W, WH;144 PCS/BG, 10 BG/CS
A PLUS INTERNATIONAL INC.
1
In Commercial Distribution

  • 80683534010064 ()
  • 00683534010068 ()
68-401W-G

  • Surgical cap, single-use
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