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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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Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48-0 VS
In Commercial Distribution

  • EJKP100003442A0 ()


  • Ultraviolet tanning device
Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48 -0
In Commercial Distribution

  • EJKP100003441A0 ()


  • Ultraviolet tanning device
Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48-0 VS
In Commercial Distribution

  • EJKP100003440A0 ()


  • Ultraviolet tanning device
Wrong Listing no was used, the correct one is D347385
JK-Products GmbH
JK 158 / 48-0
In Commercial Distribution

  • EJKP100003439A0 ()


  • Ultraviolet tanning device
Locking Screw is used to ensure sturdy positioning of instruments
Ascension Orthopedics, Inc.
10204217
In Commercial Distribution

  • M268102042171 ()
  • 10381780240761 ()

  • .477in L; .313in x .12in diamter Thread
10204217

  • Joint prosthesis implantation kit, reusable
Retainium is intended for use as a lingual retention wire
RELIANCE ORTHODONTIC PRODUCTS INC
RET
In Commercial Distribution

  • D798RET1 ()
  • D798RET0 ()
RET

  • Orthodontic retainer
Saline Solution (0.85%) is a saline solution for viral specimens.
BIO-MED DIAGNOSTICS, INC.
1612
In Commercial Distribution

  • B08816120 ()
  • B08816121 ()
  • B08816122 ()
11-612-001

  • Saline suspension medium/diluent IVD
BTS OMNIsEMG is an instrument for the electromyographic surface analysis.
BTS SPA
1.0
In Commercial Distribution

  • B179OMN ()
BTSEMB1BM

  • Electromyograph
The EsoSure Esophageal Retractor is intended to move the esophagus.
NORTH EAST SCIENTIFIC INC
100001
In Commercial Distribution

  • B2271000010 ()

  • Outer Diameter: 0.052 Inch
100001

  • Intraluminal oesophageal retractor
Disposable Patient Interface is part of the Shape-HF testing system
Shape Medical Systems, Inc.
Disposable Patient Interface
In Commercial Distribution

  • B20044001 ()


  • Pulmonary function testing kit
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