Standard Reusable Awl 903007-0000-P01

GUDID 00811714035536

3.8 mm Reusable Awl

RESPONSIVE ORTHOPEDICS LLC

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Primary Device ID00811714035536
NIH Device Record Key6bfbab7e-47c9-436c-a908-af723b52fc2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameStandard Reusable Awl
Version Model Number903007-0000-P01
Catalog Number903007-0000-P01
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 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
GS100811714035536 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


[00811714035536]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-29
Device Publish Date2022-09-21

Devices Manufactured by RESPONSIVE ORTHOPEDICS LLC

00811714035994 - Stealth2024-04-09 Stealth Drill 3.0mm
00811714036007 - Stealth2024-04-09 Stealth Castle Guide Tube
00811714036014 - Stealth2024-04-09 Stealth Soft Bone Drill 3.0mm
00811714036021 - Stealth2024-04-09 Stealth Probe
00811714036038 - Stealth2024-04-09 Stealth Blunt Probe
00811714036045 - Mini Stealth2024-04-09 Mini Stealth Drill 2.1mm
00811714036052 - Mini Stealth2024-04-09 Mini Stealth Castle Guide Tube
00811714036069 - Mini Stealth2024-04-09 Mini Stealth Probe

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