Signature -x Cement P/N191-14-4000

GUDID 03760177044326

TEKNIMED

Orthopaedic cement, antimicrobial
Primary Device ID03760177044326
NIH Device Record Keyec638ce4-f061-4f7a-b333-82cb596be117
Commercial Distribution StatusIn Commercial Distribution
Brand NameSignature -x Cement
Version Model NumberSV
Catalog NumberP/N191-14-4000
Company DUNS764746723
Company NameTEKNIMED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Operating and Storage Conditions

Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Handling Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS103760177044326 [Primary]

FDA Product Code

LODBone Cement

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-02
Device Publish Date2026-01-23

On-Brand Devices [Signature -x Cement ]

03760177044340MV
03760177044333LV
03760177044326SV

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