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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XL HEXAGONAL WRENCH /SCREW
ETABLISSEMENTS ANTHOGYR
INCHEXLV
In Commercial Distribution

  • 03663394005432 ()


  • Surgical screwdriver, reusable
LONG HEXAGONAL WRENCH /SCREW
ETABLISSEMENTS ANTHOGYR
INCHELV
In Commercial Distribution

  • 03663394005425 ()


  • Surgical screwdriver, reusable
SHORT MU GRIPPING WRENCH
ETABLISSEMENTS ANTHOGYR
MUWS
In Commercial Distribution

  • 03663394003353 ()


  • Surgical screwdriver, reusable
LONG MULTI-UNIT MANDREL
ETABLISSEMENTS ANTHOGYR
MUM100L
In Commercial Distribution

  • 03663394003339 ()


  • Surgical screwdriver, reusable
Response 5.5/6.0 Pedicle Screw Driver, ZH Drive
ORTHOPEDIATRICS CORP.
01-1300-8335
In Commercial Distribution

  • 00840194418256 ()
01-1300-8335

  • Surgical screwdriver, reusable
Response 5.5/6.0 Pedicle Screw Driver, Square Drive
ORTHOPEDIATRICS CORP.
01-1300-8035
In Commercial Distribution

  • 00840194418249 ()
01-1300-8035

  • Surgical screwdriver, reusable
5.5/6.0 Cannulated Reduction Pedicle Screw Driver, T15, Zimmer Hudson Connect
ORTHOPEDIATRICS CORP.
01-1301-6036
In Commercial Distribution

  • 00840194417877 ()


  • Surgical screwdriver, reusable
5.5/6.0 Cannulated Pedicle Screw Driver, T15, Zimmer Hudson Connect
ORTHOPEDIATRICS CORP.
01-1301-6035
In Commercial Distribution

  • 00840194417013 ()


  • Surgical screwdriver, reusable
10mm Driver, Square Drive
ORTHOPEDIATRICS CORP.
01-2200-0005
In Commercial Distribution

  • 00840194411219 ()
01-2200-0005

  • Surgical torque wrench, reusable
No Description
ORTHOPEDIATRICS CORP.
01-1300-5103
In Commercial Distribution

  • 00840194405645 ()
01-1300-5103

  • Orthopaedic surgical procedure kit, non-medicated, reusable
13mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0093
In Commercial Distribution

  • 00840194405546 ()
01-1501-0093

  • Medullary canal orthopaedic reamer shaft
12mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0092
In Commercial Distribution

  • 00840194405539 ()
01-1501-0092

  • Medullary canal orthopaedic reamer shaft
11mm Opening Reamer
ORTHOPEDIATRICS CORP.
01-1501-0091
In Commercial Distribution

  • 00840194405522 ()
01-1501-0091

  • Medullary canal orthopaedic reamer shaft
5.0mm Hex, Non-Retaining, Cannulated Driver, Long
ORTHOPEDIATRICS CORP.
01-1402-0015
In Commercial Distribution

  • 00840194404464 ()
01-1402-0015

  • Surgical screwdriver, reusable
5.0mm Hex, Non-Retaining, Cannulated Driver, Short
ORTHOPEDIATRICS CORP.
01-1402-0011
In Commercial Distribution

  • 00840194404457 ()
01-1402-0011

  • Surgical screwdriver, reusable
Abutment Driver Latch Handpiece 23mm, OverDLock Attachment System
FAICO MEDICAL LLC
LOC50075
Not in Commercial Distribution

  • 00840192718174 ()


  • Dental implant system
Abutment Driver Square Drive Torque Wrench 21mm, OverDLock Attachment System
FAICO MEDICAL LLC
LOC50071
Not in Commercial Distribution

  • 00840192718167 ()


  • Dental implant system
Abutment Driver Square Drive Torque Wrench 15mm, OverDLock Attachment System
FAICO MEDICAL LLC
LOC50070
Not in Commercial Distribution

  • 00840192718150 ()


  • Dental implant system
Ratcheting Screwdriver detachable complete. Cross Head
FAICO MEDICAL LLC
CD-001-00
Not in Commercial Distribution

  • 00840192716552 ()


  • Surgical screwdriver, reusable
Mandibular Reconstruction Plate. Thickness 2.2mm. 6+19+6 L-form. Double. 65 degrees
FAICO MEDICAL LLC
MRP-2.2-6+19+6-LL
Not in Commercial Distribution

  • 00840192714619 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 6+17+6 L-form. Double. 65 degrees
FAICO MEDICAL LLC
MRP-2.2-6+17+6-LL
Not in Commercial Distribution

  • 00840192714602 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+19+4 L-form. Double. 65 degrees
FAICO MEDICAL LLC
MRP-2.2-4+19+4-LL
Not in Commercial Distribution

  • 00840192714596 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+17+4 L-form. Double. 65 degrees
FAICO MEDICAL LLC
MRP-2.2-4+17+4-LL
Not in Commercial Distribution

  • 00840192714589 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 6+14-holes L-form. 65 degrees. Right
FAICO MEDICAL LLC
MRP-2.2-6+14-L-R
Not in Commercial Distribution

  • 00840192714572 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 6+14-holes L-form. 65 degrees. Left
FAICO MEDICAL LLC
MRP-2.2-6+14-L-L
Not in Commercial Distribution

  • 00840192714565 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+14-holes L-form. 65 degrees. Right
FAICO MEDICAL LLC
MRP-2.2-4+14-L-R
Not in Commercial Distribution

  • 00840192714558 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+14-holes L-form. 65 degrees. Left
FAICO MEDICAL LLC
MRP-2.2-4+14-L-L
Not in Commercial Distribution

  • 00840192714541 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+11-holes L-form. 65 degrees. Right
FAICO MEDICAL LLC
MRP-2.2-4+11-L-R
Not in Commercial Distribution

  • 00840192714534 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+11-holes L-form. 65 degrees. Left
FAICO MEDICAL LLC
MRP-2.2-4+11-L-L
Not in Commercial Distribution

  • 00840192714527 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+8 holes L-form. 65 degrees. Right
FAICO MEDICAL LLC
MRP-2.2-4+8-L-R
Not in Commercial Distribution

  • 00840192714510 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 4+8 holes L-form. 65 degrees. Left
FAICO MEDICAL LLC
MRP-2.2-4+8-L-L
Not in Commercial Distribution

  • 00840192714503 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 17-holes. Straight
FAICO MEDICAL LLC
MRP-2.2-17-S
Not in Commercial Distribution

  • 00840192714497 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 14-holes. Straight
FAICO MEDICAL LLC
MRP-2.2-14-S
Not in Commercial Distribution

  • 00840192714480 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 11-holes. Straight
FAICO MEDICAL LLC
MRP-2.2-11-S
Not in Commercial Distribution

  • 00840192714473 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Mandibular Reconstruction Plate. Thickness 2.2mm. 8-holes. Straight
FAICO MEDICAL LLC
MRP-2.2-8-S
Not in Commercial Distribution

  • 00840192714466 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Fracture Angulated Plate. Thickness 1.5mm. 6-holes. 9.28 mm stem
FAICO MEDICAL LLC
FRMP-1.5-6-Ang
Not in Commercial Distribution

  • 00840192714350 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Fracture Orbital Plate. Thickness 1.5mm. 4-holes. Semicircular. 10.98 mm stem
FAICO MEDICAL LLC
FRMP-1.5-4-SC
Not in Commercial Distribution

  • 00840192714343 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Fracture Plate. Thickness 1.5mm. 4-holes. Alveolar. 10.68 mm stem
FAICO MEDICAL LLC
FRMP-1.5-4-A-MS
Not in Commercial Distribution

  • 00840192714336 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Fracture Plate. Thickness 1.5mm. 4-holes. Alveolar. 7.68 mm stem
FAICO MEDICAL LLC
FRMP-1.5-4-A-SS
Not in Commercial Distribution

  • 00840192714329 ()


  • Craniofacial fixation plate, non-bioabsorbable, non-customized
Fracture Plate. Thickness 1.5mm. 6-holes. 14.68 mm stem. Straight
FAICO MEDICAL LLC
FRMP-1.5-6-S-MB
Not in Commercial Distribution

  • 00840192714312 ()


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