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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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Sklar® - 10649111239595

ABBEY NH 5 IN
SKLAR CORPORATION
97-894
In Commercial Distribution

  • 10649111239595 ()


  • Suturing needle holder, reusable

NA - 10603295148845

STERILE CASE 5 IN
DEPUY ORTHOPAEDICS, INC.
2601-04-000
In Commercial Distribution

  • 10603295148845 ()
260104000

  • Device sterilization/disinfection container, reusable

NA - 10603295148821

STERILIZATION CASE 7 IN
DEPUY ORTHOPAEDICS, INC.
2601-02-000
In Commercial Distribution

  • 10603295148821 ()
260102000

  • Device sterilization/disinfection container, reusable

PULSAVAC® - 00889024375109

Power Supply, IN/ZA
ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.
00-5150-350-08
In Commercial Distribution

  • 00889024375109 ()
00-5150-350-08

  • Surgical/orthopaedic lavage system power supply

Sklar - 10649111431074

SCHUMACHER STERNUM SHEARS8.25 IN
SKLAR CORPORATION
55-1697
In Commercial Distribution

  • 10649111431074 ()


  • Rib rongeur

Omnicap - 08056646507535

Forage cap in Sontara
OMNIA SRL
10.M0006.00
In Commercial Distribution

  • 08056646507542 ()
  • 08056646507535 ()


  • Surgical cap, single-use

Xenon - 00190376264134

RIGHT IN SITU BENDER
ALPHATEC SPINE, INC.
22CIN06-G
Not in Commercial Distribution

  • 00190376264134 ()


  • Manual orthopaedic bender, reusable

Xenon - 00190376264127

LEFT IN SITU BENDER
ALPHATEC SPINE, INC.
22CIN06-D
Not in Commercial Distribution

  • 00190376264127 ()


  • Manual orthopaedic bender, reusable

Inertia® CONNEXX™ Modular Pedicle Screw System - 00889929050293

T-25 In Situ Driver
NEXXT SPINE, LLC
I20-10-02
In Commercial Distribution

  • 00889929050293 ()


  • General internal orthopaedic fixation system implantation kit

Inertia® MIS Pedicle Screw System - 00889929018699

In Situ Driver, T15
NEXXT SPINE, LLC
I10-14-15
In Commercial Distribution

  • 00889929018699 ()


  • General internal orthopaedic fixation system implantation kit
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