| Primary Device ID | 00821925013407 |
| NIH Device Record Key | c5d9cdeb-2e91-4c71-88e8-e718ddf271be |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ANTOLI-CANDELA "SHEA'S" KNIFE 10 DEGREE BLADE ANGLE 2.67 MM BLADE LEN |
| Version Model Number | 130161 |
| Company DUNS | 007198742 |
| Company Name | Gyrus Acmi, Inc. |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925013407 [Primary] |
| JZF | TUBE, EAR SUCTION |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
[00821925013407]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-21 |
| Device Publish Date | 2018-09-07 |