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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PRFL DRL, 7.0MM CMPR FT
ARTHREX, INC.
AR-8770-03
In Commercial Distribution

  • 00888867263710 ()
AR-8770-03

  • Cannulated surgical drill bit, single-use
PRFL DRL, 5.0MM CMPR FT
ARTHREX, INC.
AR-8750-05
In Commercial Distribution

  • 00888867263703 ()
AR-8750-05

  • Cannulated surgical drill bit, single-use
3.0 Knotless Hip SutureTak Disp Drill HB
ARTHREX, INC.
AR-1938DHD
In Commercial Distribution

  • 00888867253933 ()
AR-1938DHD

  • Cannulated surgical drill bit, single-use
Multi-Driver with T-Handle
ARTHREX, INC.
AR-8964-23
In Commercial Distribution

  • 00888867241428 ()
AR-8964-23

  • Orthopaedic implant driver
Multi-Driver Adapter
ARTHREX, INC.
AR-8964-19
In Commercial Distribution

  • 00888867241374 ()
AR-8964-19

  • Orthopaedic implant driver
AO PULL RELEASE RATCHETING DRIVER
ARTHREX, INC.
AR-5050-03
In Commercial Distribution

  • 00888867233836 ()
AR-5050-03

  • Surgical instrument handle, non-torque-limiting
STERNAL WIRE DRIVER
ARTHREX, INC.
AR-5050-04
In Commercial Distribution

  • 00888867233829 ()
AR-5050-04

  • Manual wire driver
No Description
Varian Medical Systems Deutschland GmbH
GM11002980
In Commercial Distribution

  • 00816389022416 ()
GM11002980

  • General-purpose brachytherapy system applicator, remote-afterloading
Cannulated Reamer w/ K-Wire
PARCUS MEDICAL LLC
11220
In Commercial Distribution

  • 00816342025041 ()


  • Cannulated surgical drill bit, single-use
45 Knotless Push-In Suture Anchor with Driver
PARCUS MEDICAL LLC
11175
In Commercial Distribution

  • 00816342024136 ()

  • Outer Diameter: 4.5 Millimeter
11175

  • Tendon/ligament bone anchor, non-bioabsorbable
4.5mm Cannulated Reamer w/ 2.4mm Drill Tip Guide Pin
PARCUS MEDICAL LLC
11216
In Commercial Distribution

  • 00816342023993 ()


  • Cannulated surgical drill bit, single-use
35 Knotless Push-In Suture Anchor with Driver
PARCUS MEDICAL LLC
10994
In Commercial Distribution

  • 00816342023795 ()


  • Tendon/ligament bone anchor, non-bioabsorbable
Mallet
PARCUS MEDICAL LLC
10559
In Commercial Distribution

  • 00816342021531 ()


  • Surgical mallet
Reusable Driver for Knotless Anchors
PARCUS MEDICAL LLC
10487
In Commercial Distribution

  • 00816342021418 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Reusable Driver for Knotless Anchors
PARCUS MEDICAL LLC
10483
In Commercial Distribution

  • 00816342021401 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
Interference Screw Driver w/ Handle
PARCUS MEDICAL LLC
10275
In Commercial Distribution

  • 00816342021043 ()


  • Surgical screwdriver, reusable
Reusable 3.5mm Hex Driver
PARCUS MEDICAL LLC
10274
In Commercial Distribution

  • 00816342021036 ()


  • Surgical screwdriver, reusable
8" Caspar Screwdriver for Distraction Pins
Surgical Direct, Inc.
SD915218104
In Commercial Distribution

  • B382SD9152181040 ()
SD915218104

  • Surgical screwdriver, reusable
8 3/4 inch Impactor, 7mm
Surgical Direct, Inc.
SD914724101
In Commercial Distribution

  • B382SD9147241010 ()
SD914724101

  • Surgical mallet
8 3/4” Anterior Cervical Graft Driver, Guarded, 1/4” Tip
Surgical Direct, Inc.
SD914721105
In Commercial Distribution

  • B382SD9147211050 ()
SD914721105

  • Surgical tamp, reusable
MectaLock PEEK Ø3.4 – Long driver
Medacta International SA
05.11.003
In Commercial Distribution

  • 07630040727822 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
MectaLock PEEK Ø2.9 – Long driver
Medacta International SA
05.11.002
In Commercial Distribution

  • 07630040727815 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
MectaLock PEEK Ø2.4 – Long driver
Medacta International SA
05.11.001
In Commercial Distribution

  • 07630040727808 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
MectaLock PEEK Ø3.4 – Short driver
Medacta International SA
05.10.003
In Commercial Distribution

  • 07630040727778 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
MectaLock PEEK Ø2.9 – Short driver
Medacta International SA
05.10.002
In Commercial Distribution

  • 07630040727761 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
MectaLock PEEK Ø2.4 – Short driver
Medacta International SA
05.10.001
In Commercial Distribution

  • 07630040727754 ()


  • Soft-tissue/mesh anchor, non-bioabsorbable
Integra® Miltex® Nylon Replacement Cap for REF # 19-796
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-797
In Commercial Distribution

  • H834197970 ()
  • 10381780421009 ()
19-797

  • Surgical mallet
Integra® Miltex® Polyacetal, Polyoxymethylene Replacement Cap for REF #'s 19-793 and 19-794
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-795
In Commercial Distribution

  • H834197950 ()
  • 10381780420989 ()
19-795

  • Surgical mallet
Integra® Miltex® Mallet 7-1/2", Head: Weight 9oz., Diameter 1", 1 Polyacetal, Polyoxymethylene Cap
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-794
In Commercial Distribution

  • H834197940 ()
  • 10381780420972 ()
19-794

  • Surgical mallet
Integra® Miltex® Mallet 7-1/2", Head: Weight 7.5oz., Diameter 1", 2 Polyacetal, Polyoxymethylene Caps
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-793
In Commercial Distribution

  • H834197930 ()
  • 10381780420965 ()
19-793

  • Surgical mallet
Integra® Miltex® Lucae Mallet, 7-3/4", 5 Oz Head Weight, 1" Diameter
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-792
In Commercial Distribution

  • H834197920 ()
  • 10381780420958 ()

  • 5 Oz Head Weight
  • Outer Diameter: 1 Inch
  • 7-3/4"
19-792

  • Surgical mallet
Integra® Miltex® Gerzog Mallet 7-1/2", Head: Weight 8oz.
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
19-790
In Commercial Distribution

  • H834197900 ()
  • 10381780420941 ()
19-790

  • Surgical mallet
PEEK CF Interference Screw Driver
PARCUS MEDICAL LLC
10042
In Commercial Distribution

  • 00816342020374 ()
10042

  • Surgical screwdriver, reusable
Driver IF Screw 3.5mm Hex Can 1.5 mm
PARCUS MEDICAL LLC
10041
In Commercial Distribution

  • 00816342020367 ()


  • Surgical screwdriver, reusable
18MM WASHER DRIVER
ARTHREX, INC.
SP-1349H
In Commercial Distribution

  • 00888867201996 ()
SP-1349H

  • Orthopaedic implant driver
TENO SCRWDRV 7X 10 MM & 8X 12MM
ARTHREX, INC.
SP-0527
In Commercial Distribution

  • 00888867201958 ()
SP-0527

  • Surgical screwdriver, reusable
DRIVER SHAFT, T25 HEXALOBE, CANNULATED
ARTHREX, INC.
AR-8610D-65
In Commercial Distribution

  • 00888867197299 ()
AR-8610D-65

  • Surgical screwdriver, reusable
DRIVER SHAFT, T15 HEXALOBE CANNULATED
ARTHREX, INC.
AR-8610D-43
In Commercial Distribution

  • 00888867197282 ()
AR-8610D-43

  • Surgical screwdriver, reusable
DRIVER SHAFT, T7 HEXALOBE CANNULATED
ARTHREX, INC.
AR-8610D-25
In Commercial Distribution

  • 00888867197268 ()
AR-8610D-25

  • Surgical screwdriver, reusable
DRILL BIT, CANNULATED, 3.0MM
ARTHREX, INC.
AR-8610DB-43
In Commercial Distribution

  • 00888867197206 ()
AR-8610DB-43

  • Surgical screwdriver, reusable
DRILL BIT, CANNULATED, 1.7MM
ARTHREX, INC.
AR-8610DB-25
In Commercial Distribution

  • 00888867197183 ()
AR-8610DB-25

  • Surgical screwdriver, reusable
7 1/2" Orthopedic Mallet, Stainless Steel Handle 1lb 14oz
Surgical Direct, Inc.
SD9145693-1000
In Commercial Distribution

  • B382SD914569310000 ()
SD9145693-1000

  • Surgical mallet
7" Smith Peterson Mallet, Brass Head 15oz, Aluminum Black Handle
Surgical Direct, Inc.
SD914557-1000
In Commercial Distribution

  • B382SD91455710000 ()
SD914557-1000

  • Surgical mallet
8" Toronto Bone Mallet, Metal
Surgical Direct, Inc.
SD914556115
In Commercial Distribution

  • B382SD9145561150 ()
SD914556115

  • Surgical mallet
7 1/4 inch Orthopedic Mallet, Solid Stainless Steel, 1lb, 1 3/8 inch Head
Surgical Direct, Inc.
SD914556114
In Commercial Distribution

  • B382SD9145561140 ()
SD914556114

  • Surgical mallet
500 Gram Hammer, Phenolic Handle
Surgical Direct, Inc.
SD914556113
In Commercial Distribution

  • B382SD9145561130 ()
SD914556113

  • Surgical mallet
7 7/8 inch Toronto Bone Mallet
Surgical Direct, Inc.
SD914556112
In Commercial Distribution

  • B382SD9145561120 ()
SD914556112

  • Surgical mallet
Nylon Cap Replacement for SD914556102 7 1/2 Mallet, 7-1/2 9 oz. (255 G), Stainless Head 1 Diameter, with One Stainless Face and One Replaceable Nylon Cap
Surgical Direct, Inc.
SD914556111
In Commercial Distribution

  • B382SD9145561110 ()
SD914556111

  • Surgical mallet
7 1/4 inch Heath Mallet, 40mm Head Diameter, Copper Filled, 660gms
Surgical Direct, Inc.
SD914556108
In Commercial Distribution

  • B382SD9145561080 ()
SD914556108

  • Surgical mallet
Slaphammer 400gr For Small and Medium Pliers
Surgical Direct, Inc.
SD9145561060
In Commercial Distribution

  • B382SD91455610600 ()
SD9145561060

  • Surgical mallet
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