Patient tracker tabs (PU 100) U9 020 01

GUDID B057U9020010

Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references products Patient tracker EM mini or Patient tracker EM-D mini to the patient during surgery.

Scopis GmbH

Basic skin adhesive tape
Primary Device IDB057U9020010
NIH Device Record Key6c0a152a-9287-4d1b-b3b2-fedb7537f96c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePatient tracker tabs (PU 100)
Version Model Number1.0
Catalog NumberU9 020 01
Company DUNS341702266
Company NameScopis GmbH
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB057U9020000 [Unit of Use]
HIBCCB057U9020010 [Primary]

FDA Product Code

PGWEar, Nose, And Throat Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-10-23
Device Publish Date2018-01-04

Devices Manufactured by Scopis GmbH

B057U9020010 - Patient tracker tabs (PU 100)2019-10-23Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references products Patient tracker EM mini or Patient tracker EM-D mini to the patient during surgery.
B057U9020010 - Patient tracker tabs (PU 100)2019-10-23 Patient tracker tabs are circular, medical grade, double-sided adhesive tape. They serve to attach the navigation references pro
B057U1017010 - Instrument clamp 2-6 mm2018-10-22 The Instrument clamp 2-6 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. To
B057U1017020 - Instrument clamp forceps2018-10-22 The Instrument clamp forceps is part of a clamp set that provides mounting of instrument trackers to conventional instruments. T
B057U1017030 - Instrument clamp 6-10 mm2018-10-22 The Instrument clamp 6-10 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments. T
B057U1017050 - Instrument clamp 10-16 mm2018-10-22 The Instrument clamp 10-16 mm is part of a clamp set that provides mounting of instrument trackers to conventional instruments.
B057U4003260170 - NOVA AR2018-07-31 The Navigation Software NOVA AR provides import of image sets, building the image-based model of patient anatomy, planning of ta
B057U1029010 - Precision Pointer EM2018-03-29 The Precision Pointer EM is an electromagnetically tracked instrument that is used to register the patient anatomy and to naviga
B057U1029030 - Registration pointer EM-D2018-03-29 The Registration Pointer EM-D is an electromagnetically tracked instrument with a rounded, blunt tip that is used to register th

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.