“X” Osteotome, 7mm 00-9986-010-17;00-9986-010-17

GUDID 00847538001235

“X” Osteotome, 7mm

SYMMETRY MEDICAL INC.

Orthopaedic osteotome
Primary Device ID00847538001235
NIH Device Record Key9d78ea9e-6934-46e5-b793-9dbf12a58ee3
Commercial Distribution StatusIn Commercial Distribution
Brand Name“X” Osteotome, 7mm
Version Model Number10-008-000
Catalog Number00-9986-010-17;00-9986-010-17
Company DUNS079881212
Company NameSYMMETRY 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100847538001235 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00847538001235]

Moist Heat or Steam Sterilization


[00847538001235]

Moist Heat or Steam Sterilization


[00847538001235]

Moist Heat or Steam Sterilization


[00847538001235]

Moist Heat or Steam Sterilization


[00847538001235]

Moist Heat or Steam Sterilization


[00847538001235]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-20
Device Publish Date2022-05-12

On-Brand Devices [“X” Osteotome, 7mm]

00847538006360“X” Osteotome, 7mm
00847538001235“X” Osteotome, 7mm

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