SD03130005

GUDID 10886982346377

HEX COUPLING W/ FIXED HANDLE

Synthes GmbH

Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting Surgical instrument handle, non-torque-limiting

• Primary Device ID: 10886982346377
• NIH Device Record Key: f51168fd-23f9-42d2-be3f-2a794c971277
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: SD03.130.005
• Catalog Number: SD03130005
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10886982346377 [Primary]

FDA Product Code

• HTW: BIT, DRILL

Sterilization

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

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

[10886982346377]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-13
• Device Publish Date: 2024-02-05

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• 10886982344229 - NA: 2024-05-13 FOOT - 10MM UPRIGHT REDUCTION CLAMP
• 10886982344236 - NA: 2024-05-13 FOOT - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344243 - NA: 2024-05-13 HOOK - 4MM UPRIGHT REDUCTION CLAMP
• 10886982344250 - NA: 2024-05-13 HOOK - 10MM UPRIGHT REDUCTION CLAMP
• 10886982346940 - NA: 2024-05-09 60MM DEPTH PROBE FOR XL25 SCREWS
• 10886982346933 - NA: 2024-05-08 EXTENDED MULTI HOLE WIRE GUIDE FOR RFNA
• 10886982346957 - NA: 2024-05-08 FNS ANGLED GUIDE 130° W/ WIDER BASE
• 10887587078359 - NA: 2024-04-16 MANDIBLE BODY REDUCTION HANDLE