04501112S

GUDID H98004501112S0

3.0MM TI STERNAL LOCKING SCREW SELF-DRILLING/12MM - STERILE

SYNTHES (U.S.A.) LP

Sternal fixation device

Primary Device ID	H98004501112S0
NIH Device Record Key	ccee73a7-009d-4ea3-9f13-c7053bc932e0
Commercial Distribution Status	In Commercial Distribution
Version Model Number	04.501.112S
Catalog Number	04501112S
Company DUNS	832637081
Company Name	SYNTHES (U.S.A.) LP
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587017389 [Primary]
HIBCC	H98004501112S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K081700

FDA Product Code

HWC	Screw, fixation, bone

Sterilization

Steralize Prior To Use	true
Device Is Sterile	true

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

[H98004501112S0]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-14

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

10886982293060 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
10886982293237 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
10886982293251 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
10886982293268 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA	2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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