Primary Device ID | 06429830116998 |
NIH Device Record Key | 4ca98a57-4d86-4615-9e9d-1590e7a4900e |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Surgify Halo | 5.4 mm | Extendable |
Version Model Number | 54.000.SEE.H1 |
Company DUNS | 368510617 |
Company Name | Surgify Medical Oy |
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 Issuing Agency | Device ID |
---|---|
GS1 | 06429830116998 [Primary] |
HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-10 |
Device Publish Date | 2025-04-02 |
06429811532069 - Surgify Halo | 4.0 mm | Short | 2025-06-26 |
06429811532076 - Surgify Halo | 4.0 mm | Extendable | 2025-06-26 |
06429811532083 - Surgify Halo | 4.0 mm | Long | 2025-06-26 |
06429811532090 - Surgify Halo | 5.4 mm | Short | 2025-04-10 |
06429811532106 - Surgify Halo | 5.4 mm | Long | 2025-04-10 |
06429811532120 - Surgify Halo | 5.4 mm | Medium | 2025-04-10 |
06429811532137 - Surgify Halo | 5.4 mm | Long | 2025-04-10 |
06429830116998 - Surgify Halo | 5.4 mm | Extendable | 2025-04-10 |
06429830116998 - Surgify Halo | 5.4 mm | Extendable | 2025-04-10 |