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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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The Titan Reverse Shoulder humeral poly liner is designed to achieve stability of the glenohumeral joint.
Ascension Orthopedics, Inc.
LNR096000R
In Commercial Distribution

  • M269LNR096000R1 ()
  • 10381780121558 ()

  • .668 in H; Size 0
LNR-0960-00R

  • Resurfacing humeral head prosthesis
The round speed nut is used for quick temporary stabilization of the strut to the ring.
Ascension Orthopedics, Inc.
12224214
In Commercial Distribution

  • 10381780125310 ()

  • .87 in major dia x .560 in H
12224214

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional midfoot support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225060
In Commercial Distribution

  • M269122250601 ()
  • 10381780248132 ()

  • 5.702 in L
12225060

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional heel support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225050
In Commercial Distribution

  • M269122250501 ()
  • 10381780248125 ()

  • 6.238 in L
12225050

  • External orthopaedic fixation system, reusable
Integra® External Fixation System The provisional calf support is used with the external fixation system.
Ascension Orthopedics, Inc.
12225040
In Commercial Distribution

  • M269122250401 ()
  • 10381780248118 ()

  • 6.883 in L
12225040

  • External orthopaedic fixation system, reusable
Solum IV 5cc w/ BMC Plus Processing Kit - UDI is not correct per current DI# configuration.
Celling Biosciences
1205-2000
Not in Commercial Distribution

  • 00810025870089 ()
XXXX

  • Haematological concentrate system preparation kit, bone marrow concentration
  • Synthetic bone graft
ProVeil™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. ProVeil™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
PV4030
In Commercial Distribution

  • B130PV40301 ()
  • B130PV40300 ()
  • B130PV40302 ()
  • B130PV40303 ()
PV4030

  • Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS4030
In Commercial Distribution

  • B130NS40300 ()
  • B130NS40301 ()
  • B130NS40302 ()
  • B130NS40303 ()
NS4030

  • Nerve guide, animal-derived
NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries.
Checkpoint Surgical, Inc.
NS3020
In Commercial Distribution

  • B130NS30201 ()
  • B130NS30200 ()
  • B130NS30202 ()
  • B130NS30203 ()
NS3020

  • Nerve guide, animal-derived
Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The Provox Insertion System is a single-use replacement device intended for anterograde insertion only.
Atos Medical AB
8287
In Commercial Distribution

  • 07331791010910 ()

  • Length: 15 Millimeter
  • Diameter Outer - Fr 22.5
8287

  • Tracheoesophageal speech valve, indwelling
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