Awl 90-RAA-405000

GUDID 00811714030005

Awl

RESPONSIVE ORTHOPEDICS LLC

Bone awl
Primary Device ID00811714030005
NIH Device Record Key7e58c5a6-d92f-4cc8-b88e-341959453b78
Commercial Distribution StatusIn Commercial Distribution
Brand NameAwl
Version Model Number90-RAA-405000
Catalog Number90-RAA-405000
Company DUNS002745858
Company NameRESPONSIVE ORTHOPEDICS LLC
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 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
GS100811714030005 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-31
Device Publish Date2019-05-23

On-Brand Devices [Awl]

00811714030005Awl
00811714034362Awl
008117140354755.5 mm Reusable Awl

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