| Primary Device ID | 00840085276989 |
| NIH Device Record Key | c14d3e40-a740-41f8-9cfc-ad4bee754784 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | MZA110000 |
| Catalog Number | MZA110000 |
| Company DUNS | 073029645 |
| Company Name | Astura Medical |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM | |
| Phone | 7608148047 |
| PARKER@ASTURAMEDICAL.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840085276989 [Primary] |
| GAD | Retractor |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
[00840085276989]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-09 |
| Device Publish Date | 2025-12-01 |
| 00840085233500 - DOLOMITE | 2025-12-10 STRAIGHT TAMP |
| 00840085233517 - DOLOMITE | 2025-12-10 ROTATION TAMP |
| 00840085233524 - DOLOMITE | 2025-12-10 LOCK DRIVER |
| 00840085235078 - DOLOMITE | 2025-12-10 SCREWDRIVER, T10A |
| 00840085235085 - DOLOMITE | 2025-12-10 SCREW REMOVER, T10A |
| 00840085236938 - DOLOMITE | 2025-12-10 FIXED ANGLE DRIVER |
| 00840085236990 - DOLOMITE | 2025-12-10 FIXED ANGLE LOCK DRIVER |
| 00840085242274 - DOLOMITE | 2025-12-10 FIXED ANGLE DRIVER BIT SOCKET |