03000207S

GUDID H98003000207S0

BURR CONICAL LENGTH 23MM Ø 5.0MM W/J-LATCH COUPLING

SYNTHES (U.S.A.) LP

Orthopaedic bur, reusable

• Primary Device ID: H98003000207S0
• NIH Device Record Key: a9916823-c6a3-4814-b351-0d65d2b19de6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 03.000.207S
• Catalog Number: 03000207S
• Company DUNS: 832637081
• Company Name: SYNTHES (U.S.A.) LP
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10887587009063 [Primary]
HIBCC	H98003000207S0 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-30

Devices Manufactured by SYNTHES (U.S.A.) LP

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• H9812982060 - NA: 2024-07-24 ANGLED LAMINA HOOK/ DUAL-OPENING SIDE
• H6792042280 - NA: 2024-07-24 3.5MM SHAFT SCREW 28MM
• H6792042320 - NA: 2024-07-24 3.5MM SHAFT SCREW 32MM
• H6792042340 - NA: 2024-07-24 3.5MM SHAFT SCREW 34MM
• H6792042360 - NA: 2024-07-24 3.5MM SHAFT SCREW 36MM
• H6792042380 - NA: 2024-07-24 3.5MM SHAFT SCREW 38MM