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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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XcelGel - 00810048240203

PC1003 Foot Section with cutout 20" x 20" x 1/2"
POLYMER CONCEPTS, INC.
PC1003
In Commercial Distribution

  • 00810048240203 ()


  • Operating table patient pressure distribution pad, reusable

Phasix - 00801741107603

Phasix Mesh, 8" x 8" (20 cm x 20 cm), Square
Davol Inc.
1192020
In Commercial Distribution

  • 00801741107603 ()

  • Length: 20 Centimeter
  • Width: 20 Centimeter
1192020

  • Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

GRADIA® - 14548161282970

GRADIA® Cartridge(1CORE Cartridge 10 mL (20 g), 20 GC Automix Tips for Endo, 20 Extension Tips)
Gc America Inc.
003652
In Commercial Distribution

  • 14548161282970 ()
003652

  • Dental composite resin

GRADIA® - D0470036521

GRADIA® Cartridge(1CORE Cartridge 10 mL (20 g), 20 GC Automix Tips for Endo, 20 Extension Tips)
Gc America Inc.
003652
In Commercial Distribution

  • D0470036521 ()
003652

  • Dental composite resin

DISPOSABLE KIT W/ OSSEOTI IMPLANT - 00880304806382

No Description
Biomet Orthopedics, LLC
110027855
In Commercial Distribution

  • 00880304806382 ()

  • 20 MM 20 MM
110027855

  • Orthopaedic bone staple, non-adjustable

OviTex® 2S - 09421904065413

The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10258-2020G
In Commercial Distribution

  • 09421904065413 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

OviTex® 1S - 09421904065345

The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10256-2020G
In Commercial Distribution

  • 09421904065345 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

OviTex® Core - 09421904065277

The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10254-2020G
In Commercial Distribution

  • 09421904065277 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial

OviTex® 2S - 09421904065208

The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10248-2020P
In Commercial Distribution

  • 09421904065208 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, biologic-polymer composite

OviTex® 1S - 09421904065130

The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10246-2020P
In Commercial Distribution

  • 09421904065130 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, biologic-polymer composite

OviTex® Core - 09421904065062

The OviTex® Reinforced Tissue Matrix Device is a sterile reinforced matrix device comprised of non-dermal sourced layers of extracellular matrix (ECM) (ovine (sheep) derived ECM), paired with a minimal suture footprint. OviTex Reinforced Tissue Matrix Device provides an alternative device solution to permanent synthetic, resorbable/bioabsorbable synthetic, and biologic meshes. The device remodels and helps regenerate tissue while reinforcing the repair and providing structural support. Reinforced tissue matrices enhance performance while maintaining compatibility with the body. The OviTex Reinforced Tissue Matrix Device is used for hernia repair and abdominal wall reconstruction.
AROA BIOSURGERY LIMITED
F10244-2020P
In Commercial Distribution

  • 09421904065062 ()

  • 20 x 20 cm


  • Extra-gynaecological surgical mesh, biologic-polymer composite

OSSIOfiber® Compression Staple - 07290017630892

OSSIOfiber® Compression Staple, 20x20 mm. Package contains: 1 Implant.
OSSIO LTD
OF1062020S
In Commercial Distribution

  • 07290017630892 ()

  • 20 x 20 mm
OF1062020S

  • Orthopaedic bone staple, non-adjustable

OSSIOfiber® Compression Staple System - 07290017630700

OSSIOfiber® Compression Staple System, 20 x 20 mm. Package contains: 1 Implant, and 1 Instrument pack.
OSSIO LTD
OF2062020S
In Commercial Distribution

  • 07290017630700 ()

  • 20 x 20 mm
OF2062020S

  • Orthopaedic surgical procedure kit, non-medicated, single-use
  • Orthopaedic bone staple, non-adjustable

HEPRO.US Insulin Syringes attached needle 0.3ml/cc 29G x 5/16" - 00850578007457

Case of 20 boxes of Insulin Syringes attached needle 0.3ml/cc 29G x 5/16"
HEPRO.US INC.
CT - 0.3ml/cc 29G x 5/16"
In Commercial Distribution

  • 00850578007457 ()
  • 85057800745702 ()


  • Insulin syringe/needle, basic

Dover - 10192253030563

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 30 CC, 2-WAY
Cardinal Health 200, LLC
23020ICC
Not in Commercial Distribution

  • 20192253030560 ()
  • 10192253030563 ()
  • 50192253030561 ()
23020ICC

  • Indwelling urethral drainage balloon catheter, antimicrobial

Dover - 10192253030495

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20520ICC
Not in Commercial Distribution

  • 20192253030492 ()
  • 10192253030495 ()
  • 50192253030493 ()
20520ICC

  • Indwelling urethral drainage balloon catheter, antimicrobial

Dover - 10192253066272

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 30 CC, 2-WAY
Cardinal Health 200, LLC
23020ICC
In Commercial Distribution

  • 20192253066279 ()
  • 10192253066272 ()
  • 50192253066270 ()
23020ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

Dover - 10192253066241

100% SILICONE SILVER-HYDROGEL COATED FOLEY CATHETER, COUDE TIP, 20 FR (6.7 MM), 5 CC, 2-WAY
Cardinal Health 200, LLC
20520ICC
In Commercial Distribution

  • 20192253066248 ()
  • 10192253066241 ()
  • 50192253066249 ()
20520ICC

  • Indwelling urethral drainage balloon catheter, non-antimicrobial

20 DEGREE MICROFRACTURE PICK - 00880304411227

No Description
Biomet Orthopedics, LLC
909102
In Commercial Distribution

  • 00880304411227 ()
909102

  • Orthopaedic prosthesis implantation positioning instrument, reusable

TwitchView2 Patient Cable 20' - 00850023319173

No Description
BLINK DEVICE COMPANY
TVCAB05
In Commercial Distribution

  • 00850023319173 ()
TVCAB05

  • Block-monitoring peripheral nerve electrical stimulation system

20 MHz B-Scan Probe - 00857377006124

The DGH1920 is a single-element mechanical sector B-scan probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.
DGH TECHNOLOGY INC.
DGH1920
In Commercial Distribution

  • 00857377006124 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system

AnchorKnot Suture Cutter (2-0) - 00685447002116

No Description
Baylis Médicale Cie Inc
PSZ-400-308
Not in Commercial Distribution

  • 00685447002116 ()


  • Suture trimmer

AnchorKnot Knot Pusher (2-0) - 00685447002079

No Description
Baylis Médicale Cie Inc
PSZ-400-302
Not in Commercial Distribution

  • 00685447002079 ()


  • Suture knot pusher, single-use

AnchorKnot Suture Passer (2-0) - 00685447001744

No Description
Baylis Médicale Cie Inc
PSZ-400-305
Not in Commercial Distribution

  • 00685447001744 ()


  • Suturing unit, single-use

TRUE® 20 hCG - 00657498001356

A Qualitative Immunoassay for the Detection of Human Chorionic Gonadotropin (hCG) in Urine.
STANBIO LABORATORY, L.P.
1430-050
In Commercial Distribution

  • 00657498001356 ()
  • 00657498001363 ()
1430-050

  • Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

CODAN Luer-Lock 20 ml - 05706225001147

CODAN Luer-Lock 20 ml, single use, syringe, sterile
Codan Medical ApS
62.7704
In Commercial Distribution

  • 05706225001123 ()
  • 05706225001147 ()


  • General-purpose syringe, single-use

Micro 20 Gauge Tip - 00883205022400

Micro 20 Gauge Tips 500pk
ULTRADENT PRODUCTS, INC.
1437
In Commercial Distribution

  • 00883205022400 ()
1437

  • Syringe tip cap

Micro 20 Gauge Tip - 00883205022080

Micro 20 Gauge Tips 100pk
ULTRADENT PRODUCTS, INC.
1252
In Commercial Distribution

  • 00883205022080 ()
1252

  • Syringe tip cap

Micro 20 Gauge Tip - 00883205022028

Micro 20 Gauge Tips 20pk
ULTRADENT PRODUCTS, INC.
1168
In Commercial Distribution

  • 00883205022028 ()
1168

  • Dental suction system cannula, single-use

CASSETTE STAINLESS 20 INST. - D9281073200

No Description
W.H. Holden, Inc.
10-7320
In Commercial Distribution

  • D9281073200 ()


  • Instrument tray, reusable
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