IMPULSION

GUDID 03663394170871

KEY

ETABLISSEMENTS ANTHOGYR

Orthopaedic implant/instrument dismantling device

• Primary Device ID: 03663394170871
• NIH Device Record Key: 63fe2218-1137-48e9-b62e-e38727e48999
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPULSION
• Version Model Number: 87M
• Company DUNS: 275978864
• Company Name: ETABLISSEMENTS ANTHOGYR
• Device Count: 1
• DM Exempt: true
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03663394170871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093894

FDA Product Code

• EFA: Handpiece, belt and/or gear driven, dental

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-21
• Device Publish Date: 2025-02-13

Devices Manufactured by ETABLISSEMENTS ANTHOGYR

• 03663394170871 - IMPULSION: 2025-02-21KEY
• 03663394170871 - IMPULSION: 2025-02-21 KEY
• 03663394482332 - Anthogyr OSTEOTOME: 2024-07-25 EMPTY OSTEOTOMY TRAY
• 03663394011099 - TORQCONTROL: 2024-04-05 DYNAMOMETRIC C.A TORQCONTROL
• 03663394173346 - Anthogyr UNIVERSAL SURGICAL INSTRUMENT: 2024-03-06 UNIVERSAL SURGICAL INSTRUMENT
• 03663394482936 - AXIOM®: 2024-01-31 BALL WRENCH XL
• 03663394484275 - AXIOM®: 2024-01-29 PIN SLEEVE Ø2.0
• 03663394484282 - AXIOM®: 2024-01-29 Guide sleeve Ø2.0
• 03663394484299 - AXIOM®: 2024-01-29 GUIDE SLEEVE Ø3.6 ETKON