Awl 285942

GUDID 00811714036304

Awl

RESPONSIVE ORTHOPEDICS LLC

Bone awl, reusable
Primary Device ID00811714036304
NIH Device Record Keyf2afc6d6-b34b-4636-b40c-376a86ba01b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameAwl
Version Model Number285942
Catalog Number285942
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
GS100811714036304 [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 Date2025-05-22
Device Publish Date2025-05-14

On-Brand Devices [Awl]

00811714030005Awl
00811714034362Awl
008117140354755.5 mm Reusable Awl
008117140363115.5 mm Reusable Awl
00811714036304Awl

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