Retractor Distractor

GUDID 00811331013610

Right alignment distractor

Tz Medical, Inc.

Bone tap, single-use
Primary Device ID00811331013610
NIH Device Record Key2c8c485e-8b4a-4113-a48e-d28f18e535d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameRetractor Distractor
Version Model NumberDP-72-CDR
Company DUNS793149709
Company NameTz Medical, Inc.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100811331013610 [Primary]

FDA Product Code

KDCInstrument, Surgical, Disposable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-20
Device Publish Date2025-02-12

On-Brand Devices [Retractor Distractor]

00811331013634Left alignment distractor
00811331013610Right alignment distractor

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.