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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Setscrew driver SHORT Removable locking handle
Medacta International SA
03.52.10.0714
In Commercial Distribution

  • 07630345704269 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Setscrew driver LONG Removable locking handle
Medacta International SA
03.52.10.0713
In Commercial Distribution

  • 07630345704252 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Quick screw driver - SHORT version Removable locking handle
Medacta International SA
03.52.10.0710
In Commercial Distribution

  • 07630345704245 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Quick screw driver - LONG version Removable locking handle
Medacta International SA
03.52.10.0709
In Commercial Distribution

  • 07630345704238 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
Alif Straight tapered driver
Medacta International SA
03.30.10.1970
In Commercial Distribution

  • 07630345701565 ()


  • Orthopaedic surgical procedure kit, non-medicated, reusable
MectaLock PEEK - Ø6.5 - Short driver
Medacta International SA
05.10.006
In Commercial Distribution

  • 07630345701466 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
MectaLock PEEK - Ø5.5 - Short driver
Medacta International SA
05.10.005
In Commercial Distribution

  • 07630345701459 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
MectaLock PEEK - Ø4.5 - Short driver
Medacta International SA
05.10.004
In Commercial Distribution

  • 07630345701442 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
Fixed Driver / Slim Standard Axial Handle / ZSJ-Hall Coupling / Cannulated / Black
Arch Medical Solutions Corp.
1FL2-C01
In Commercial Distribution

  • 00817247021725 ()
1FL2-C01

  • Surgical instrument handle, non-torque-limiting
Fixed Driver / Slim T-Handle / ZSJ Hall Coupling / Blue
Arch Medical Solutions Corp.
2FT15-C09
In Commercial Distribution

  • 00817247020056 ()


  • Surgical instrument handle, non-torque-limiting
GLOBAL QUICK CONNECT DRIVER SHAFT
DEPUY ORTHOPAEDICS, INC.
2230-81-600
In Commercial Distribution

  • 10603295383826 ()
223081600

  • Drilling power tool attachment, basic
GLOBAL CAP HUMERAL HEAD SHAPER 48mm x 21mm
DEPUY ORTHOPAEDICS, INC.
2230-81-550
In Commercial Distribution

  • 10603295383772 ()
223081550

  • Orthopaedic bur, reusable
GLOBAL CAP HUMERAL HEAD SHAPER 44mm x 18mm
DEPUY ORTHOPAEDICS, INC.
2230-81-530
In Commercial Distribution

  • 10603295383758 ()
223081530

  • Orthopaedic bur, reusable
SUMMIT MAKE TO ORDER 30-DEG STEM INSERTER
DEPUY ORTHOPAEDICS, INC.
2999-60-730
In Commercial Distribution

  • 10603295328100 ()
299960730

  • Orthopaedic inorganic implant inserter/extractor, reusable
ANCILLAIRE PE RETENTIF
DEPUY (IRELAND)
L95470
In Commercial Distribution

  • 10603295325420 ()
L95470

  • Orthopaedic inorganic implant inserter/extractor, reusable
REEF
DEPUY (IRELAND)
L93582
In Commercial Distribution

  • 10603295261469 ()
L93582

  • Surgical screwdriver, reusable
Grater Handle
DEPUY INTERNATIONAL LTD
9798-10-000
In Commercial Distribution

  • 10603295251552 ()
979810000

  • Orthopaedic inorganic implant inserter/extractor, reusable
8mm BALL HEX DRIVER
DEPUY (IRELAND)
4812-00-100
In Commercial Distribution

  • 10603295510284 ()
481200100

  • Orthopaedic inorganic implant inserter/extractor, reusable
DISCOVERY, PIN DRIVER
AURORA SPINE, INC.
DISCOVERY
In Commercial Distribution

  • B5211053030 ()
105-303

  • Orthopaedic surgical procedure kit, non-medicated, reusable
No Description
Zimmer, Inc.
4502-25
In Commercial Distribution

  • 00889024115118 ()

  • 2.5 mm Diameter
00-4502-025-00

  • Surgical screwdriver, reusable
No Description
Zimmer, Inc.
00-4089-008-01
In Commercial Distribution

  • 00889024114364 ()
00-4089-008-01

  • Orthopaedic prosthesis implantation positioning instrument, reusable
No Description
Zimmer, Inc.
1001-01
Not in Commercial Distribution

  • 00889024113275 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
No Description
Zimmer, Inc.
1001
Not in Commercial Distribution

  • 00889024113268 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
INHANCE INTACT HUMERAL DRIVE SHAFT
DEPUY (IRELAND)
6231-31-014
In Commercial Distribution

  • 10603295559825 ()
623131014

  • Surgical drill guide, reusable
Lock Cover Driver
Eisertech, LLC
100065-0
In Commercial Distribution

  • B5231000650 ()
100065-0

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
Cervical Plate Screw Driver
Eisertech, LLC
100057-0
In Commercial Distribution

  • B5231000570 ()
100057-0

  • Orthopaedic fixation plate, non-bioabsorbable, non-sterile
INHANCE INTACT GLENOID DRIVE SHAFT
DEPUY (IRELAND)
6231-31-008
In Commercial Distribution

  • 10603295559436 ()
623131008

  • Surgical drill guide, reusable
ATTUNE TM MAKE TO ORDER CLASSIC SLAP HAMMER ASSEMBLY
DEPUY ORTHOPAEDICS, INC.
2999-58-248
In Commercial Distribution

  • 10603295555476 ()
299958248

  • Surgical mallet
INHANCE SHOULDER SYSTEM STAR DRIVER 20
DEPUY (IRELAND)
7505-10-103
In Commercial Distribution

  • 10603295552611 ()
750510103

  • Orthopaedic inorganic implant inserter/extractor, single-use
INHANCE SHOULDER SYSTEM READY- SET GO REVERSE KIT NA NA
DEPUY (IRELAND)
7705-55-500
In Commercial Distribution

  • 10603295551805 ()
770555500

  • Joint prosthesis implantation kit, single-use
SiLO TFX Flex Retaining Driver
AURORA SPINE, INC.
114-315
In Commercial Distribution

  • B5211143150 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
SILO, BONE ANCHOR DRIVER
AURORA SPINE, INC.
113-303
In Commercial Distribution

  • B5211133030 ()


  • Sacroiliac joint transarticular fixation/arthrodesis implantation kit
PINNACLE MAKE TO ORDER DUAL OFFSET CUP IMPACTOR
DEPUY ORTHOPAEDICS, INC.
2999-66-927
In Commercial Distribution

  • 10603295549253 ()
299966927

  • Orthopaedic inorganic implant inserter/extractor, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER - BOWTIE SMALL
DEPUY (IRELAND)
6205-60-030
In Commercial Distribution

  • 10603295539483 ()
620560030

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM DRIVER
DEPUY (IRELAND)
6205-10-105
In Commercial Distribution

  • 10603295539421 ()
620510105

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM STEM INSERTER BOLT
DEPUY (IRELAND)
6201-01-161
In Commercial Distribution

  • 10603295539353 ()
620101161

  • Orthopaedic surgical distractor, internal
INHANCE SHOULDER SYSTEM CANNULATED IMPACTOR HANDLE
DEPUY (IRELAND)
6201-01-141
In Commercial Distribution

  • 10603295539339 ()
620101141

  • Orthopaedic inorganic implant inserter/extractor, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR X-LARGE
DEPUY (IRELAND)
6105-30-060
In Commercial Distribution

  • 10603295538950 ()
610530060

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR LARGE
DEPUY (IRELAND)
6105-30-050
In Commercial Distribution

  • 10603295538943 ()
610530050

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR MEDIUM
DEPUY (IRELAND)
6105-30-040
In Commercial Distribution

  • 10603295538936 ()
610530040

  • Bone-resection orthopaedic reamer, reusable
INHANCE SHOULDER SYSTEM ONE STEP PREP GLENOID REAMER – CIRCULAR X- SMALL
DEPUY (IRELAND)
6105-30-020
In Commercial Distribution

  • 10603295538912 ()
610530020

  • Bone-resection orthopaedic reamer, reusable
SCREW DRIVER, HEX HEAD
Encore Medical, L.P.
801-01-042
In Commercial Distribution

  • 00888912127165 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
DRIVER,HEX REVISION
DJO, LLC
800-01-263
In Commercial Distribution

  • 00888912123495 ()


  • Orthopaedic prosthesis implantation positioning instrument, reusable
Staple Tamp, Large
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000002
In Commercial Distribution

  • B471240000020 ()


  • Orthopaedic bone staple driver
Staple Tamp, Small
GRAMERCY EXTREMITY ORTHOPEDICS LLC
24000001
In Commercial Distribution

  • B471240000010 ()


  • Orthopaedic bone staple driver
Drill Bit 5.0mmx230mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250230
In Commercial Distribution

  • B471212502300 ()

  • Outer Diameter: 5.0 Millimeter
  • Length: 230 Millimeter


  • Cannulated surgical drill bit, single-use
Drill Bit 5.0mmx160mm ZH Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21250160
In Commercial Distribution

  • B471212501600 ()

  • Length: 160 Millimeter
  • Outer Diameter: 5.0 Millimeter


  • Cannulated surgical drill bit, single-use
Cannulated Drill, AO, 1.9mm x 135mm
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21119135
In Commercial Distribution

  • B471211191350 ()


  • Cannulated surgical drill bit, single-use
Drill Bit 2.8mmx150mm AO Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21028150
In Commercial Distribution

  • B471210281500 ()

  • Outer Diameter: 2.8 Millimeter
  • Length: 150 Millimeter


  • Cannulated surgical drill bit, single-use
Drill Bit 2.8mmx100mm AO Cannulated
GRAMERCY EXTREMITY ORTHOPEDICS LLC
21028100
In Commercial Distribution

  • B471210281000 ()

  • Outer Diameter: 2.8 Millimeter
  • Length: 100 Millimeter


  • Cannulated surgical drill bit, single-use
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