Flexible Awl

GUDID 09348215044619

SIGNATURE ORTHOPAEDICS PTY LTD

Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable Bone awl, reusable
Primary Device ID09348215044619
NIH Device Record Key6ef6fb89-bbca-442a-984a-d4b473b621f5
Commercial Distribution StatusIn Commercial Distribution
Brand NameFlexible Awl
Version Model NumberW32-01-1020
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215044619 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[09348215044619]

Moist Heat or Steam Sterilization


[09348215044619]

Moist Heat or Steam Sterilization


[09348215044619]

Moist Heat or Steam Sterilization


[09348215044619]

Moist Heat or Steam Sterilization


[09348215044619]

Moist Heat or Steam Sterilization


[09348215044619]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-10
Device Publish Date2018-10-05

On-Brand Devices [Flexible Awl]

09348215067762132-23-0050
09348215044619W32-01-1020
09348215044602W32-01-0050

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