05001051

GUDID 07611819167971

DURA GUARD-SHORT FOR PEN DRIVE

Synthes GmbH

Surgical instrument guard, reusable

• Primary Device ID: 07611819167971
• NIH Device Record Key: a703d5ec-3cd6-4a0a-aea0-4191938dee59
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 05.001.051
• Catalog Number: 05001051
• Company DUNS: 486711679
• Company Name: Synthes GmbH
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611819167971 [Direct Marking]
GS1	10886982128782 [Primary]
HIBCC	H679050010510 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043310

FDA Product Code

• ERL: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

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

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

[07611819167971]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-04-18
• Device Publish Date: 2016-06-30

Devices Manufactured by Synthes GmbH

• 07612334285515 - VOLT: 2024-12-19 VOLT(TM) PROX HUM IMP & INSTR 1 HIGH 3/3 WIDTH ALUM TRAY
• 10886982346896 - MAXFRAME: 2024-12-17 MAXFRAME AUTOSTRUT (TM) SOFTWARE
• 10886982347572 - NA: 2024-12-11 RFN-ADVANCED POLYMER INLAY STERILE
• 10886982330994 - VOLT: 2024-11-22 2.0MM VOLT(TM) ADAPTION PLATE 12H/65MM
• 07612334260079 - KINCISE: 2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
• 07612334268587 - KINCISE: 2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID
• 07612334268679 - KINCISE: 2024-11-08 KINCISE(TM) SYSTEM PRIMARY HIP ADAPTER CASE
• 07612334268563 - KINCISE: 2024-11-04 KINCISE™ System Automated Surgical Handpiece V2