04204050

GUDID H679042040500

4.0MM TI LOCKING SCR SLF-TPNG WITH T25 STARDRIVE RECESS 50MM

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, non-sterile
Primary Device IDH679042040500
NIH Device Record Keyf9fab102-9cb9-4ba3-ba9d-9c6b60e8e958
Commercial Distribution Discontinuation2019-07-17
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number04.204.050
Catalog Number04204050
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 Datefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982116246 [Primary]
HIBCCH679042040500 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPLATE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679042040500]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-17
Device Publish Date2015-09-14

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H6792042320 - NA2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA2024-07-24 3.5MM SHAFT SCREW 38MM

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