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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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CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 4
Shalby Advanced Technologies, Inc.
2267-0-0004
In Commercial Distribution

  • 00840286851589 ()
2267-0-0004

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 3
Shalby Advanced Technologies, Inc.
2267-0-0003
In Commercial Distribution

  • 00840286851572 ()
2267-0-0003

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 2
Shalby Advanced Technologies, Inc.
2267-0-0002
In Commercial Distribution

  • 00840286851565 ()
2267-0-0002

  • Uncoated knee femur prosthesis, metallic
CKS, Femoral Component, RLP, CR, TiNbN Coating, Left, Size 1
Shalby Advanced Technologies, Inc.
2267-0-0001
In Commercial Distribution

  • 00840286851558 ()
2267-0-0001

  • Uncoated knee femur prosthesis, metallic
The mBrace Model 4275 is a wrist support device that extends the patient's wrist at a consistent 40°angle with a syringe clip to attach a syringe.
Semler Technologies, Inc.
4275
In Commercial Distribution

  • 20815614020160 ()
  • 10815614020163 ()
140-0275-00

  • Wrist immobilizer, single-use
The mBrace Model 4250 is a wrist support device that extends the patient's wrist at a consistent 40°angle with a hook to integrate with an ArmBoard.
Semler Technologies, Inc.
4250
In Commercial Distribution

  • 20815614020153 ()
  • 10815614020156 ()
140-0250-00

  • Wrist immobilizer, single-use
No Description
NEUROLOGICA CORP.
0-00135-002
In Commercial Distribution

  • 10815411020557 ()


  • Head/neck procedure positioner
No Description
ENCISION, INC.
BP7200L
In Commercial Distribution

  • 10815288013898 ()
BP7200L

  • Electrosurgical handpiece, reusable
PEG Safety Kit Push Technique
CORPAK MEDSYSTEMS, INC.
30-4320-S7
In Commercial Distribution

  • 20815149025357 ()
  • 10815149025350 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4320-S7

  • Ultraviolet phototherapy unit, professional
PEG Kit Push Technique; with snare
CORPAK MEDSYSTEMS, INC.
30-4020-S7
In Commercial Distribution

  • 20815149025340 ()
  • 10815149025343 ()

  • 20 FR (6.7mm)
  • Catheter Gauge: 20 French
30-4020-S7

  • Ultraviolet phototherapy unit, professional
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