03164021

GUDID 07612334216748

DRILL BIT Ø3.5MM QC LENGTH 380 MM

Synthes GmbH

Fluted surgical drill bit, single-use

• Primary Device ID: 07612334216748
• NIH Device Record Key: dcd95157-ba05-4faa-a1b3-d1fb6006b867
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.164.021
• Catalog Number: 03164021
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07612334216748 [Direct Marking]
GS1	10886982311207 [Primary]

FDA Product Code

• HTW: BIT, DRILL

Sterilization

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

[07612334216748]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-12-07
• Device Publish Date: 2022-11-29

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