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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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Straumann Regenomer - 08809186542067

Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB2-L
In Commercial Distribution

  • 08809186542067 ()

  • 8mm X 7mm X 9mm


  • Dental bone matrix implant, animal-derived

Straumann Regenomer - 08809186542050

Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types,Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSB1-S
In Commercial Distribution

  • 08809186542050 ()

  • 6mm X 5mm X 7mm


  • Dental bone matrix implant, animal-derived

Straumann Regenomer - 08809186542043

Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP2-L
In Commercial Distribution

  • 08809186542043 ()

  • 12mm X 25mm


  • Dental bone matrix implant, animal-derived

Straumann Regenomer - 08809186542036

Straumann® Regenomer® is a sponge-like absorbable and porous collagen designed to be used as bone filling augmentation material. The device is manufactured from purified type I collagen derived from porcine skin sources in South Korea. The porcine skin is certified by veterinarian and is obtained by a standardized controlled manufacturing process. Straumann® Regenomer® is manufactured in three types, Straumann® Regenomer® Syringe (sheet shape in syringe and blister), Straumann® Regenomer® Plug (bullet shape in blister), and Straumann® Regenomer® Block (block shape in blister). Straumann® Regenomer® are supplied sterile, non-pyrogenic, and for single use only.
Nibec Co., Ltd.
RSP1-S
In Commercial Distribution

  • 08809186542036 ()

  • 8mm X 18mm


  • Dental bone matrix implant, animal-derived

TRUMATCH - 05420060380761

Midface Reconstruction kit
Materialise NV
SD980.032
In Commercial Distribution

  • 05420060380761 ()
SD980.032

  • Custom-made organ/bone anatomy model/surgical guide kit

TRUMATCH - 05420060380754

Mandible Reconstruction kit
Materialise NV
SD980.031
In Commercial Distribution

  • 05420060380754 ()
SD980.031

  • Custom-made organ/bone anatomy model/surgical guide kit

TRUMATCH - 05420060380747

Titanium 3D Printed Guide, Bone harvesting
Materialise NV
SD980.028
In Commercial Distribution

  • 05420060380747 ()
SD980.028

  • Custom-made orthopaedic/craniofacial surgical guide

ARVIS ® - 00850012315124

2.5mm Ball Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
11100
In Commercial Distribution

  • 00850012315124 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

ARVIS ® - 00850012315117

3.5mm Hex Driver
KICO KNEE INNOVATION COMPANY PTY LIMITED
10800
In Commercial Distribution

  • 00850012315117 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable

OsteoCentric Headless Compression System 2.0mm Hex Driver Shaft Cannulated - 00850015496394

Headless Compression System 2.0mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0033
In Commercial Distribution

  • 00850015496394 ()
EX01-0033

  • Surgical screwdriver, reusable

OsteoCentric Headless Compression System 1.5mm Hex Driver Shaft Cannulated - 00850015496387

Headless Compression System 1.5mm Hex Driver Shaft Cannulated
Osteocentric Technologies, Inc.
EX01-0032
In Commercial Distribution

  • 00850015496387 ()
EX01-0032

  • Surgical screwdriver, reusable

Lumbar Interbody Fusion System (OLLIF) - 00850014575489

Lumbar Interbody Fusion System (OLLIF) Mallet
ADVANCED RESEARCH MEDICAL LLC
01-11
In Commercial Distribution

  • 00850014575489 ()
01-11

  • Surgical mallet

Pillow Passive Driver Kit - 00850011790229

No Description
RESOUNDANT, INC.
REFDAUX
In Commercial Distribution

  • 00850011790229 ()


  • Magnetic resonance elastography acoustic driver

Active Driver - 00850011790168

No Description
RESOUNDANT, INC.
RESYS4001
In Commercial Distribution

  • 00850011790168 ()


  • Magnetic resonance elastography acoustic driver

MR Elastography System - 00850011790151

No Description
RESOUNDANT, INC.
RESYS4001-RESYSAB
In Commercial Distribution

  • 00850011790151 ()


  • Magnetic resonance elastography acoustic driver

Passive Driver - 00850011790106

No Description
RESOUNDANT, INC.
REPD2000
In Commercial Distribution

  • 00850011790106 ()


  • Magnetic resonance elastography acoustic driver

Flex Passive Driver Kit- Small - 00850011790052

No Description
RESOUNDANT, INC.
REFPDS19
In Commercial Distribution

  • 00850011790052 ()


  • Magnetic resonance elastography acoustic driver

Flex Passive Driver Kit- Large - 00850011790045

No Description
RESOUNDANT, INC.
REFPDL18
In Commercial Distribution

  • 00850011790045 ()


  • Magnetic resonance elastography acoustic driver

Resoundant Acoustic Driver System - 00850011790021

No Description
RESOUNDANT, INC.
RESY3002-RESYSAB
In Commercial Distribution

  • 00850011790021 ()


  • Magnetic resonance elastography acoustic driver

L-Varlock - 00850011324097

Instrument, Expansion Screwdriver, Long
SPINESOURCE INC
097
In Commercial Distribution

  • 00850011324097 ()
SD-4100

  • Surgical screwdriver, reusable

Corin Taper-Fit Total Hip System - 05055196940604

ALLEN KEY
CORIN LTD
11903
In Commercial Distribution

  • 05055196940604 ()
11903

  • Surgical screwdriver, reusable

Rotaglide+ Modular Knee System with Fixed Meniscus - 05055196939639

IM rod T-handle locking collar spanner
CORIN LTD
340.313
In Commercial Distribution

  • 05055196939639 ()
340.313

  • Surgical screwdriver, reusable

Trinity Acetabular Hip System - 05055196926639

MODULAR SCREWDRIVER (1/4" SQ CONNECTION)
CORIN LTD
921.112
In Commercial Distribution

  • 05055196926639 ()
921.112

  • Surgical screwdriver, reusable

Trinity Acetabular Hip System - 05055196926622

MODULAR UJ SCREWDRIVER (1/4" SQ CONNECTION)
CORIN LTD
921.113
In Commercial Distribution

  • 05055196926622 ()
921.113

  • Surgical screwdriver, reusable

Rotaglide+ Modular Knee System with Fixed Meniscus - 05055196921078

Pin driver
CORIN LTD
291.607
In Commercial Distribution

  • 05055196921078 ()
291.607

  • Orthopaedic inorganic implant inserter/extractor, reusable

Rotaglide+ Modular Knee System with Fixed Meniscus - 05055196917125

Boss peg screwdriver socket
CORIN LTD
202.110
In Commercial Distribution

  • 05055196917125 ()
202.110

  • Surgical screwdriver, reusable

Uniglide Unicondylar Knee Prosthesis - 05055196908123

C-ARM IMPACTOR
CORIN LTD
BC8K-2G01-000
In Commercial Distribution

  • 05055196908123 ()
BC8K-2G01-000

  • Orthopaedic implant driver

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis - 05055196905252

INTRODUCER LOCKING BAR
CORIN LTD
S279.843
In Commercial Distribution

  • 05055196905252 ()
S279.843

  • Surgical screwdriver, reusable

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis - 05055196901209

HAMMER
CORIN LTD
379.094
In Commercial Distribution

  • 05055196901209 ()
379.094

  • Surgical mallet

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis - 05055196901162

LOCKING SCREW WRENCH
CORIN LTD
379.126
In Commercial Distribution

  • 05055196901162 ()
379.126

  • Surgical screwdriver, reusable

Rotaglide+ Modular Knee System with Fixed Meniscus - 05055196901148

Locking screw wrench (T-handle)
CORIN LTD
379.123
In Commercial Distribution

  • 05055196901148 ()
379.123

  • Surgical screwdriver, reusable

Unity Total Knee System - 05055196901032

3.5 mm A/F Hex
CORIN LTD
279.018
In Commercial Distribution

  • 05055196901032 ()
279.018

  • Surgical screwdriver, reusable

Unity Total Knee System - 05055343892695

Hex Attachment 2.5 mm
CORIN LTD
CG000167
In Commercial Distribution

  • 05055343892695 ()
CG000167

  • Surgical screwdriver, reusable

Trinity Acetabular Hip System - 05055343891391

Enztec Offset Reamer Driver – Large AO
CORIN LTD
3991064
In Commercial Distribution

  • 05055343891391 ()
3991064

  • Surgical instrument handle, non-torque-limiting

Trinity Acetabular Hip System - 05055343891308

Enztec Offset Reamer Driver – Hudson
CORIN LTD
3991065
In Commercial Distribution

  • 05055343891308 ()
3991065

  • Surgical instrument handle, non-torque-limiting

Trinity Acetabular Hip System with HXLPE Liners - 05055343886908

FLEXIBLE DRILL DRIVER
CORIN LTD
921.098
In Commercial Distribution

  • 05055343886908 ()
921.098

  • Orthopaedic implant impactor, reusable

Unity Total Knee System - 05055343886847

Pin Driver (Hudson)
CORIN LTD
H123.350.00
In Commercial Distribution

  • 05055343886847 ()
H123.350.00

  • Orthopaedic inorganic implant inserter/extractor, reusable

Unity Total Knee System - 05055343886830

Pin Driver (AO)
CORIN LTD
A123.350.00
In Commercial Distribution

  • 05055343886830 ()
A123.350.00

  • Orthopaedic inorganic implant inserter/extractor, reusable

Unity Total Knee System - 05055343886823

Pin Driver (Hall Zimmer)
CORIN LTD
123.350.00
In Commercial Distribution

  • 05055343886823 ()
123.350.00

  • Orthopaedic inorganic implant inserter/extractor, reusable

TriFit TS Blade Stem - 05055343880135

SLOTTED MALLET
CORIN LTD
695.500
In Commercial Distribution

  • 05055343880135 ()
695.500

  • Surgical mallet

Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis - 05055343878415

MODULAR DRIVE SHAFT STRYKER DRIVE
CORIN LTD
379.068
In Commercial Distribution

  • 05055343878415 ()
379.068

  • Surgical screwdriver, reusable

MiniHip Stem - 05055343876602

MiniHip - Universal screw Handle
CORIN LTD
580.9041.03
In Commercial Distribution

  • 05055343876602 ()
580.9041.03

  • Surgical screwdriver, reusable

OXFORD ANKLE FUSION NAIL(AFN) SYSTEM - 05055662944785

AFN MISS 5MM CANNULATED DRILL
ORTHO SOLUTIONS HOLDINGS LIMITED
OS333525
In Commercial Distribution

  • 05055662944785 ()
OS333525

  • Cannulated surgical drill bit, single-use

ORTHO SOLUTIONS STERILE DRILL BITS - 05055662932935

2.3MM PHALANGEAL SCREW CANNULATED DRILL
ORTHO SOLUTIONS HOLDINGS LIMITED
OS319052
In Commercial Distribution

  • 05055662932942 ()
  • 05055662932935 ()
OS319052

  • Cannulated surgical drill bit, single-use

Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932768

AO QC COMPRESSION SCREW DRILL 22MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310206
In Commercial Distribution

  • 05055662932751 ()
  • 05055662932768 ()
OS310206

  • Cannulated surgical drill bit, single-use

Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932720

AO QC COMPRESSION SCREW DRILL 12MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310204
In Commercial Distribution

  • 05055662932713 ()
  • 05055662932720 ()
OS310204

  • Cannulated surgical drill bit, single-use

Ortho Solutions Extremity Fixation Implants for Osteosysnthesis - 05055662932706

AO QC COMPRESSION SCREW DRILL 18MM
ORTHO SOLUTIONS HOLDINGS LIMITED
OS310203
In Commercial Distribution

  • 05055662932690 ()
  • 05055662932706 ()
OS310203

  • Cannulated surgical drill bit, single-use

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662928952

SCARF SCREW DRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS320053
In Commercial Distribution

  • 05055662928952 ()
OS320053

  • Surgical screwdriver, reusable

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662928884

WEIL SCREW SOLID DRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS319056
In Commercial Distribution

  • 05055662928884 ()
OS319056

  • Surgical screwdriver, reusable

ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS - 05055662928877

2.3MM PHALANGEAL SCREW CANNULATED DRIVER SHANK
ORTHO SOLUTIONS HOLDINGS LIMITED
OS319054
In Commercial Distribution

  • 05055662928877 ()
OS319054

  • Surgical screwdriver, reusable
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