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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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4CIS® INSTRUMENT SYSTEM - 08806373581632

Closed Ring
ALPHANOX CO.,LTD.
9807-0051
In Commercial Distribution

  • 08806373581632 ()
9807-0051

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373581502

Lordotic Cage Caddy
ALPHANOX CO.,LTD.
9901-5036
In Commercial Distribution

  • 08806373581502 ()
9901-5036

  • Device sterilization/disinfection container, reusable
  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373581496

Anatomical Cage Caddy
ALPHANOX CO.,LTD.
9901-5035
In Commercial Distribution

  • 08806373581496 ()
9901-5035

  • Device sterilization/disinfection container, reusable
  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373581489

Instrument Case
ALPHANOX CO.,LTD.
9901-5034
In Commercial Distribution

  • 08806373581489 ()
9901-5034

  • Device sterilization/disinfection container, reusable
  • External spinal fixation system

4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM - 08806373581472

4CIS® Pinehurst Plate Holder
ALPHANOX CO.,LTD.
5932-1114
In Commercial Distribution

  • 08806373581472 ()
5932-1114

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373581335

ARTICULATING ROD INSERTER
ALPHANOX CO.,LTD.
9807-0021
In Commercial Distribution

  • 08806373581335 ()
9807-0021

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373581243

Ring
ALPHANOX CO.,LTD.
9807-0050
In Commercial Distribution

  • 08806373581243 ()
9807-0050

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373581236

Counter Torque
ALPHANOX CO.,LTD.
9807-0049
In Commercial Distribution

  • 08806373581236 ()
9807-0049

  • External spinal fixation system

4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM - 08806373581229

4CIS® Pinehurst Single DTS
ALPHANOX CO.,LTD.
5932-1112
In Commercial Distribution

  • 08806373581229 ()
5932-1112

  • External spinal fixation system

4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM - 08806373581212

4CIS® Pinehurst Double DTS
ALPHANOX CO.,LTD.
5932-1111
In Commercial Distribution

  • 08806373581212 ()
5932-1111

  • External spinal fixation system

4CIS® PINEHURST ANTERIOR CERVICAL PLATE SYSTEM - 08806373581205

4CIS® Pinehurst Temporary Fixation Pin
ALPHANOX CO.,LTD.
5932-1117
In Commercial Distribution

  • 08806373581205 ()
5932-1117

  • External spinal fixation system

4CIS® INSTRUMENT SYSTEM - 08806373581199

AO I-Handle
ALPHANOX CO.,LTD.
5932-1124
In Commercial Distribution

  • 08806373581199 ()
5932-1124

  • External spinal fixation system

NA - 10887587078274

SELF-RETAINING SCRWDRVR BLADE FOR 90°SCRWDRVR
Synthes GmbH
SD03.501.750
In Commercial Distribution

  • 10887587078274 ()
SD03501750

  • Surgical screwdriver, reusable

Reicodent - 04061644052790

Interchange plastic inserts for Art No. 02-860-50
devemed GmbH
02-860-50 A
In Commercial Distribution

  • 04061644052790 ()


  • Surgical mallet

MatrixMIDFACE - 10887587076027

TI MATRIXMIDFACE ADAPTION PL 8 HOLES 0.5MM FOR 1.3MM SCREW
Synthes GmbH
04.503.221
In Commercial Distribution

  • 10887587076027 ()
04503221

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

MatrixMIDFACE - 10887587076010

TI MATRIXMIDFACE ORBIT RIM PL 9 HOLES 0.5MM FOR 1.3MM SCREW
Synthes GmbH
04.503.220
In Commercial Distribution

  • 10887587076010 ()
04503220

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

MatrixMIDFACE - 10887587076003

TI MATRIXMIDFACE ADAPTION PL 24 HOLES 0.5MM FOR 1.3MM SCREW
Synthes GmbH
04.503.219
In Commercial Distribution

  • 10887587076003 ()
04503219

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

Reicodent - 04061644049561

Mallet "Vicker" | 17 cm / 180 g with interchangeable plastic inserts Hollow handle
devemed GmbH
02-860-50
In Commercial Distribution

  • 04061644049561 ()


  • Surgical mallet

NA - 10887587071671

90 DEGREE SCREWDRIVER T-HANDLE
Synthes GmbH
SD03.505.005
In Commercial Distribution

  • H980SD035050050 ()
  • 10887587071671 ()
SD03505005

  • Surgical screwdriver, reusable

NA - 10887587066622

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/6MM BAR
SYNTHES (U.S.A.) LP
SD447.199
Not in Commercial Distribution

  • 10887587066622 ()
  • H980SD4471990 ()
SD447199

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587066615

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/16MM BAR
SYNTHES (U.S.A.) LP
SD447.204
Not in Commercial Distribution

  • 10887587066615 ()
  • H980SD4472040 ()
SD447204

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587066608

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/14MM BAR
SYNTHES (U.S.A.) LP
SD447.203
Not in Commercial Distribution

  • 10887587066608 ()
  • H980SD4472030 ()
SD447203

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587066592

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/12MM BAR
SYNTHES (U.S.A.) LP
SD447.202
Not in Commercial Distribution

  • 10887587066592 ()
  • H980SD4472020 ()
SD447202

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587066585

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/10MM BAR
SYNTHES (U.S.A.) LP
SD447.201
Not in Commercial Distribution

  • 10887587066585 ()
  • H980SD4472010 ()
SD447201

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

NA - 10887587066578

2.0MM TI4 SAGITTAL SPLIT PLATE STRAIGHT/6 HOLES/8MM BAR
SYNTHES (U.S.A.) LP
SD447.200
Not in Commercial Distribution

  • 10887587066578 ()
  • H980SD4472000 ()
SD447200

  • Craniofacial fixation plate, non-bioabsorbable, non-customized

RapidSorb - 10887587064383

2.0MM RAPID RESORB CONTOURABLE MESH 50MM DIA/1.2MM THK-STER
Synthes GmbH
852.641.01S
In Commercial Distribution

  • H98085264101S0 ()
  • 10887587064383 ()
85264101S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064376

2.0MM RAPID RESORBABLE MESH 78MMX78MMX1.2MM-STERILE
Synthes GmbH
852.521.01S
In Commercial Distribution

  • H98085252101S0 ()
  • 10887587064376 ()
85252101S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064369

2.0MM RAPID RESORBABLE MESH 48MMX48MMX1.2MM-STERILE
Synthes GmbH
852.520.01S
In Commercial Distribution

  • H98085252001S0 ()
  • 10887587064369 ()
85252001S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064352

2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX18 HOLES-STERILE
Synthes GmbH
852.421.01S
In Commercial Distribution

  • H98085242101S0 ()
  • 10887587064352 ()
85242101S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064345

2.0MM RAPID RESORBABLE STRUT PLATE 2 HOLESX10 HOLES-STERILE
Synthes GmbH
852.420.01S
In Commercial Distribution

  • H98085242001S0 ()
  • 10887587064345 ()
85242001S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064338

2.0MM RAPID RESORBABLE Y-PLATE 4X3X3 HOLES-STERILE
Synthes GmbH
852.343.01S
In Commercial Distribution

  • H98085234301S0 ()
  • 10887587064338 ()
85234301S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064307

2.0MM RAPID RESORBABLE OBLIQUE L-PLATE 6H X 4H/RIGHT-STERILE
Synthes GmbH
852.264.01S
In Commercial Distribution

  • H98085226401S0 ()
  • 10887587064307 ()
85226401S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064291

2.0MM RAPID RESORBABLE OBLIQUE L-PLATE 6H X 4H/LEFT-STERILE
Synthes GmbH
852.263.01S
In Commercial Distribution

  • H98085226301S0 ()
  • 10887587064291 ()
85226301S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064284

2.0MM RAPID RESORBABLE ORBITAL RIM PLATE 10 HOLES-STERILE
Synthes GmbH
852.110.01S
In Commercial Distribution

  • H98085211001S0 ()
  • 10887587064284 ()
85211001S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064277

2.0MM RAPID RESORB ADAPTION PLATE 20 HOLES-STERILE
Synthes GmbH
852.020.01S
In Commercial Distribution

  • H98085202001S0 ()
  • 10887587064277 ()
85202001S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064260

2.0MM RAPID RESORBABLE ADAPTION PLATE 8 HOLES-STERILE
Synthes GmbH
852.008.01S
In Commercial Distribution

  • H98085200801S0 ()
  • 10887587064260 ()
85200801S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064253

2.0MM RAPID RESORBABLE STRAIGHT PLATE 4 HOLES-STERILE
Synthes GmbH
852.004.01S
In Commercial Distribution

  • H98085200401S0 ()
  • 10887587064253 ()
85200401S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064246

2.0MM RAPID RESORBABLE STRAIGHT PLATE 2 HOLES-STERILE
Synthes GmbH
852.002.01S
In Commercial Distribution

  • H98085200201S0 ()
  • 10887587064246 ()
85200201S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064222

1.5MM RAPID RESORB STRAIGHT ROW MESH/75X75X0.8MM THK-STER
Synthes GmbH
851.724.01S
In Commercial Distribution

  • H98085172401S0 ()
  • 10887587064222 ()
85172401S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064215

1.5MM RAPID RESORB STRAIGHT ROW MESH 100X100X0.8MM-STERILE
Synthes GmbH
851.722.01S
In Commercial Distribution

  • H98085172201S0 ()
  • 10887587064215 ()
85172201S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064208

1.5MM RAPID RESORB STRAIGHT ROW MESH 50MMX50MMX0.8MM-STER
Synthes GmbH
851.721.01S
In Commercial Distribution

  • H98085172101S0 ()
  • 10887587064208 ()
85172101S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064192

1.5MM RAPID RESORB STRAIGHT ROW MESH 100X100X0.5MM-STERILE
Synthes GmbH
851.712.01S
In Commercial Distribution

  • H98085171201S0 ()
  • 10887587064192 ()
85171201S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064185

1.5MM RAPID RESORB STRAIGHT ROW MESH 50MMX50MMX0.5MM-STER
Synthes GmbH
851.711.01S
In Commercial Distribution

  • H98085171101S0 ()
  • 10887587064185 ()
85171101S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064178

1.5MM RAPID RESORB ORBTL FL PL W/BENDING TEMPLATE/35MM-STER
Synthes GmbH
851.691.01S
In Commercial Distribution

  • H98085169101S0 ()
  • 10887587064178 ()
85169101S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064161

1.5MM RAPID RESORB ORBTL FL PL W/BENDING TEMPLATE/30MM-STER
Synthes GmbH
851.690.01S
In Commercial Distribution

  • H98085169001S0 ()
  • 10887587064161 ()
85169001S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064154

1.5MM RAPID RESORB ORBTL FL PL W/BENDING TEMPLATE/24MM-STER
Synthes GmbH
851.689.01S
In Commercial Distribution

  • H98085168901S0 ()
  • 10887587064154 ()
85168901S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064147

1.5MM RAPID RESORB SELLAR FLR PL 7MMX25MM/0.8MM THK-STERILE
Synthes GmbH
851.681.01S
In Commercial Distribution

  • H98085168101S0 ()
  • 10887587064147 ()
85168101S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064130

1.5MM RAPID RESORB SELLAR FLR PL 7MMX25MM/0.5MM THK-STERILE
Synthes GmbH
851.680.01S
In Commercial Distribution

  • H98085168001S0 ()
  • 10887587064130 ()
85168001S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064123

1.5MM RAPID RESORB CONTOURABLE MESH 100MM DIA/0.8MM THK-STER
Synthes GmbH
851.662.01S
In Commercial Distribution

  • H98085166201S0 ()
  • 10887587064123 ()
85166201S

  • Craniofacial fixation plate, bioabsorbable

RapidSorb - 10887587064116

1.5MM RAPID RESORB CONTOURABLE MESH 50MM DIA/0.8MM THICK-STE
Synthes GmbH
851.661.01S
In Commercial Distribution

  • H98085166101S0 ()
  • 10887587064116 ()
85166101S

  • Craniofacial fixation plate, bioabsorbable
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