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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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SOVEREIGN™ Spinal System - 00613994550767

TRAY 7960061 BOTTOM CASE 2 OF 2
MEDTRONIC SOFAMOR DANEK, INC.
7960061
In Commercial Distribution

  • 00613994550767 ()


  • Instrument tray, reusable

Medtronic Transportation/Sterilization Cassette - 00643169631700

TRAY 2159007 OLIF INSTRUMENTS 2 OF 2
MEDTRONIC SOFAMOR DANEK, INC.
2159007
In Commercial Distribution

  • 00643169631700 ()


  • Instrument tray, reusable

INFINITY™ Occipitocervical Upper Thoracic System - 00643169839465

TRAY 3607014 C3-C7 IMPLANT 2 OF 2
MEDTRONIC SOFAMOR DANEK, INC.
3607014
In Commercial Distribution

  • 00643169839465 ()


  • Instrument tray, reusable

INFINITY™ Occipitocervical Upper Thoracic System - 00643169839441

TRAY 3607011 C3-C7 INSTRUMENT 2 OF 2
MEDTRONIC SOFAMOR DANEK, INC.
3607011
In Commercial Distribution

  • 00643169839441 ()


  • Instrument tray, reusable

Sklar - 10649111443039

HEMINGWAY BONE CUR 2/2 6.75 INCHES
SKLAR CORPORATION
40-7182
In Commercial Distribution

  • 10649111443039 ()


  • Bone curette, reusable

Sklar - 10649111434396

HESS CAPSULE FCP 2 1/2 INCHES
SKLAR CORPORATION
66-5526
In Commercial Distribution

  • 10649111434396 ()


  • Surgical soft-tissue manipulation forceps, tweezers-like, reusable

Surgical Direct - B382SDM313000

Lowman Bone Clamps, 18cm, 2 x 2
Surgical Direct, Inc.
SDM31300
In Commercial Distribution

  • B382SDM313000 ()
SDM31300

  • Dressing/utility forceps, scissors-like, reusable

Arthrex® - 00888867446076

Femoral Nail System, Case 2 of 2
ARTHREX, INC.
AR-9097C-02
In Commercial Distribution

  • 00888867446076 ()
AR-9097C-02

  • Device sterilization/disinfection container, reusable

Surgical Direct - B382SD914546800

8 1/2" Orthopedic Mallet, 2 lb
Surgical Direct, Inc.
SD91454680
In Commercial Distribution

  • B382SD914546800 ()
SD91454680

  • Surgical mallet

Surgical Direct - B382SD9010711060

2 1/2" Cooley Bulldog Clamp, Curved
Surgical Direct, Inc.
SD901071106
In Commercial Distribution

  • B382SD9010711060 ()
SD901071106

  • Dressing/utility forceps, scissors-like, reusable
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