400834E

GUDID H980400834E0

TI LOW PROFILE NEURO SCREW SELF-DRILLING 4MM

SYNTHES (U.S.A.) LP

Craniofacial bone screw, non-bioabsorbable, sterile

Primary Device ID	H980400834E0
NIH Device Record Key	e389d5c8-1671-4051-abd6-edc8c251275d
Commercial Distribution Status	In Commercial Distribution
Version Model Number	400.834E
Catalog Number	400834E
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	10887587045429 [Primary]
HIBCC	H980400834E0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K022012

FDA Product Code

JEY	PLATE, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

Moist Heat or Steam Sterilization

[H980400834E0]

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

10886982297280 - NA	2024-09-11 SCHANZ PIN REMOVAL TOOL
H9814871830 - Click'X	2024-09-11 7.0MM TI CLICK'X® MONOAXIAL PEDICLE SCREW 90MM THRD LENGTH
H9812982060 - NA	2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
H6792042280 - NA	2024-07-24 3.5MM SHAFT SCREW 28MM
H6792042320 - NA	2024-07-24 3.5MM SHAFT SCREW 32MM
H6792042340 - NA	2024-07-24 3.5MM SHAFT SCREW 34MM
H6792042360 - NA	2024-07-24 3.5MM SHAFT SCREW 36MM
H6792042380 - NA	2024-07-24 3.5MM SHAFT SCREW 38MM

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