03043018

GUDID 07612334170996

INSERTION HANDLE/ RADIOLUCENT SHORT

SYNTHES (U.S.A.) LP

Orthopaedic implant/trial-implant/sizer holder, reusable

Primary Device ID	07612334170996
NIH Device Record Key	c8b6baf1-b815-4653-aa50-00d3d96a042e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	03.043.018
Catalog Number	03043018
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	false
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612334170996 [Direct Marking]
GS1	10886982297174 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K201336

FDA Product Code

JDS	NAIL, FIXATION, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

[07612334170996]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2020-12-18
Device Publish Date	2020-12-10

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

H981PDL432F - NA	2026-02-09 INLAY PUSHER-MEDIUM
H981PDL434H - NA	2026-02-09 INLAY PUSHER-LARGE
07611819995796 - NA	2026-02-09 TAMP
07611819943490 - NA	2026-02-09 HEAD IMPACTOR
H679E51157P09 - NA	2026-02-09 PLASTIC TIP FOR HEAD IMPACTOR
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

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