| Primary Device ID | 10841307123644 |
| NIH Device Record Key | cebf0a65-4dde-43b7-a1f6-676c01a31968 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Surgical Kit Grommet - Large (2pk) |
| Version Model Number | SKG- L |
| Company DUNS | 868856969 |
| Company Name | IMPLANT DIRECT SYBRON MANUFACTURING LLC |
| Device Count | 2 |
| 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 | 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841307123647 [Unit of Use] |
| GS1 | 10841307123644 [Primary] |
| NDP | Accessories, Implant, Dental, Endosseous |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
[10841307123644]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-10-21 |
| Device Publish Date | 2017-06-23 |