474920S

GUDID H679474920S0

15MM TI END CAP 0MM EXT-STER FOR STANDARD LOCKING SLEEVE

SYNTHES (U.S.A.) LP

Bone nail end-cap, sterile
Primary Device IDH679474920S0
NIH Device Record Key29d1f70b-eb6b-4928-bf8e-2ced80400e75
Commercial Distribution Discontinuation2019-10-12
Commercial Distribution StatusIn Commercial Distribution
Version Model Number474.920S
Catalog Number474920S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982234391 [Primary]
HIBCCH679474920S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDNIMPLANT, FIXATION DEVICE, SPINAL

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


[H679474920S0]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-09-19
Device Publish Date2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

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10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
10886982293251 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
10886982293268 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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