| Primary Device ID | 08057639712097 |
| NIH Device Record Key | 7578ea1f-1c54-435e-ab46-d858c578bb53 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Handle - Asym. - Ergal |
| Version Model Number | 38046 |
| Company DUNS | 338319497 |
| Company Name | MC BIO SRL |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08057639712097 [Primary] |
| EJB | Handle, Instrument, Dental |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
[08057639712097]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-07-01 |
| Device Publish Date | 2025-06-23 |
| 08057639710567 - Specialist Organizer | 2025-07-01 Specialist Organizer for MCBio tacks |
| 08057639710574 - Tip with Indexable Stop | 2025-07-01 Tip with Indexable Stop for MCBio Tacks |
| 08057639710598 - Offset Tip SP | 2025-07-01 Offset Tip Specialist for MCbio Tacks |
| 08057639710604 - Long Tip SP | 2025-07-01 Long Tip Specialist for MCBio tacks |
| 08057639710628 - GBR MODULAR SET | 2025-07-01 GBR MODULAR SET of MCBio |
| 08057639710635 - 5 Scraper box | 2025-07-01 5 Scraper box |
| 08057639711960 - G-Special box | 2025-07-01 G-Special box |
| 08057639711977 - Modular Box | 2025-07-01 Modular Box of MCBio |