04045362S

GUDID 10886982295095

LOW PROF LCKNG SCREW F/IM NAIL Ø 5.0MM / L 62MM / XL25/ STER

SYNTHES (U.S.A.) LP

Orthopaedic bone screw, non-bioabsorbable, sterile

• Primary Device ID: 10886982295095
• NIH Device Record Key: d1549af7-9b69-484d-a5cb-81a8045e6d4a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 04.045.362S
• Catalog Number: 04045362S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982295095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201336

FDA Product Code

• HWC: Screw, fixation, bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

[10886982295095]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-17
• Device Publish Date: 2021-06-09

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