0431585001

GUDID H98004315850010

2.4MM TI RAISED HEAD EMERG SCR SELF-TAPPING/PLUSDRIVE®/10MM

SYNTHES (U.S.A.) LP

Craniofacial bone screw, non-bioabsorbable, sterile

Primary Device ID	H98004315850010
NIH Device Record Key	bdb40218-12af-4c33-af51-63a7ab7804c8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	04.315.850.01
Catalog Number	0431585001
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	false
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	10887587071947 [Primary]
HIBCC	H98004315850010 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K162594

FDA Product Code

MQN	EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

[H98004315850010]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2019-12-20
Device Publish Date	2019-12-12

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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