MI Broach Handle 01.15.10.0725

GUDID 00854515008347

Unique Surgical

Surgical instrument handle, non-torque-limiting
Primary Device ID00854515008347
NIH Device Record Key1c94de0a-47e0-46d9-b549-7aaab12f726f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMI Broach Handle
Version Model NumberPincer, Offset, Left
Catalog Number01.15.10.0725
Company DUNS079820535
Company NameUnique Surgical
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone818-813-8527
Emailinfo@UniqueSurgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854515008347 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00854515008347]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-13
Device Publish Date2023-01-05

On-Brand Devices [MI Broach Handle]

00854515008477Posterior
00854515008354Pincer, Offset, Right
00854515008347Pincer, Offset, Left

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