UNIUM 05001601

GUDID 07611819654174

UNIUM(TM) MODULAR HANDPIECE

Synthes GmbH

Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Surgical power tool system handpiece, rotary, rechargeable battery-powered Bone/joint surgical power tool motor, electric Bone/joint surgical power tool motor, electric

• Primary Device ID: 07611819654174
• NIH Device Record Key: e0216d03-8496-4945-8e42-02647ac961b2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UNIUM
• Version Model Number: 05.001.601
• Catalog Number: 05001601
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819654174 [Direct Marking]
GS1	10886982309549 [Primary]

FDA Product Code

• HWE: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Sterilization

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

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

[07611819654174]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-20
• Device Publish Date: 2021-09-10

On-Brand Devices [UNIUM]

• 07612334221957: LID, WASHING & STERILIZATION BASKET 1/2 UNIUM(TM)
• 07612334221971: INSERT TRAY, WASHING BASKET UNIUM(TM)
• 07612334221964: LID, WASHING & STERILIZATION BASKET 1/1 UNIUM(TM)
• 07612334098856: WASHING & STERILIZATION BASKET 1/2 UNIUM(TM) RECIPROCATING
• 07612334098849: WASHING & STERILIZATION BASKET 1/1 UNIUM(TM) MODULAR
• 07612334079183: TRINKLE QUICK COUPLING, MODIFIED, SBD II / UNIUM(TM)
• 07612334079176: TRINKLE QUICK COUPLING, SBD II / UNIUM(TM)
• 07612334079169: HUDSON QC FOR REAMING, SBD II / UNIUM(TM)
• 07612334079152: AO/ASIF QC FOR REAMING, SBD II / UNIUM(TM)
• 07611819677128: QC FOR KIRSCHNER WIRES Ø 0.6 TO 3.2 MM, UNIUM(TM)
• 07611819655423: UNIUM(TM) TOP FOR STERNUM FOR RECIP SAW HANDPIECE
• 07611819655416: UNIUM(TM) RECIPROCATING SAW HANDPIECE
• 07611819654204: UNIUM(TM) ADAPTER FOR UBC II
• 07611819654198: UNIUM(TM) STERILE COVER
• 07611819654181: UNIUM(TM) POWER UNIT
• 07611819654174: UNIUM(TM) MODULAR HANDPIECE
• 07612334263384: LID, WASHING & STERILIZATION BASKET, 1/3
• 07612334263360: WASHING & STERILIZATION BASKET 1/3, UNIUM(TM) MODULAR
• 07612334263353: WASHING & STERILIZATION BASKET 1/1,FOR 2 UNIUM(TM) MODULAR H
• 07612334269256: TRINKLE QUICK COUPLING, MODIFIED, DRILL, UNIUM(TM)
• 07612334269560: SQUARE QUICK COUPLING, TAP/SCREW, SBDII/UNIUM(TM)
• 07612334269553: SQUARE QUICK COUPLING, FOR DRILLING, SBDII/UNIUM(TM)