Primary Device ID | J00711004720011 |
NIH Device Record Key | 33f2fa89-649d-492e-94aa-963abd43fc79 |
Commercial Distribution Discontinuation | 2023-02-08 |
Commercial Distribution Status | Not in Commercial Distribution |
Brand Name | Bur PM2-70 80K steel twist drill Ø1.1x4mm sterile |
Version Model Number | 1100472 |
Catalog Number | 1100472-001 |
Company DUNS | 481597719 |
Company Name | Bien-Air Surgery SA |
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 | 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 |
---|---|
HIBCC | J00711004720011 [Primary] |
HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-02-09 |
Device Publish Date | 2019-01-07 |
07630055508072 - PM2-S MIS | 2025-03-31 |
17630055508093 - PM2-Nose MIS D150 | 2025-03-31 |
17630055512601 - PM2-Nose MIS P160 | 2025-03-31 |
17630055506266 - Bur PM2-MIS D150 steel Ø2.0 St | 2025-03-31 |
17630055506273 - Bur PM2-MIS D150 steel Ø3.0 St | 2025-03-31 |
17630055506280 - Bur PM2-MIS D150 diam Ø2.0 St | 2025-03-31 |
17630055506297 - Bur PM2-MIS D150 diam Ø3.0 St | 2025-03-31 |
17630055506303 - Bur PM2-MIS D150 Mstick Ø1.8 St | 2025-03-31 |