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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Guidline 4000 ™ 5.0 1.5m Special-use Lead, 1x For use with microTargeting ™ Electrodes
FHC, INC.
C0232-00781
In Commercial Distribution

  • 00873263007815 ()

  • Length: 1.5 Meter
C0232

  • Depth electrode
MIS 13CM Hooded
STRYKER CORPORATION
5407-120-950H
In Commercial Distribution

  • 07613327402261 ()
5407120950H

  • Drilling power tool attachment, basic
MIS 16CM Hooded
STRYKER CORPORATION
5407-120-970H
In Commercial Distribution

  • 07613327402230 ()
5407120970H

  • Drilling power tool attachment, basic
No Description
Humeca B.V.
4.D80STS
In Commercial Distribution

  • 08717903490419 ()
  • 08717903490365 ()
4.D80STS

  • Dermatome handpiece, electrically-powered
Reusable Powered Handle
Covidien LP
IDRVULTRA1
Not in Commercial Distribution

  • 10884521142794 ()


  • Open-surgery manual linear stapler, reusable
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has several models. Different models are distinguished by needle gauge and length. The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
11G-2091-K
In Commercial Distribution

  • 86971227402543 ()
  • 06971227402547 ()


  • Autoinjector needle
The products are sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. There has several models. Different models are distinguished by needle gauge and length. The Blood Lancet consists of needle tube and needle hub. The products are for OTC use, and they are external communication, blood indirect devices. The contact duration for both subjected devices is within 24h, and they belong to limited contact device according ISO 10993-1.
Promisemed Hangzhou Meditech Co., Ltd.
11G-2090-J
In Commercial Distribution

  • 06971227402530 ()
  • 86971227402536 ()


  • Autoinjector needle
VECTOR CALIBRATION DEVICE
Stryker Leibinger GmbH & Co. KG
6000-008-000
In Commercial Distribution

  • 04546540401632 ()
6000-008-000

  • Robotic surgical navigation system
POINTER, STRAIGHT
Stryker Leibinger GmbH & Co. KG
6007-011-000
In Commercial Distribution

  • 04546540392114 ()
6007-011-000

  • Stereotactic surgery system probe, reusable
PATIENT TRACKER, BLUE
Stryker Leibinger GmbH & Co. KG
6007-010-000
In Commercial Distribution

  • 04546540392107 ()
6007-010-000

  • Patient positioning sensor
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