| Primary Device ID | 10858733006038 |
| NIH Device Record Key | 67966bc5-9b0d-4e45-a6f6-e348bca0e5bd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COTIE - Intracorporeal Knot Placement Assist Device and Collar Papillary Muscle |
| Version Model Number | 7.0 |
| Catalog Number | MI-COTIE-001 |
| Company DUNS | 073724333 |
| Company Name | Biorep Technologies, 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 | 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 |
|---|---|
| GS1 | 00858733006031 [Primary] |
| GS1 | 10858733006038 [Package] Contains: 00858733006031 Package: Shelf Box [6 Units] In Commercial Distribution |
| DWS | Instruments, Surgical, Cardiovascular |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
[10858733006038]
Radiation Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-01 |
| Device Publish Date | 2024-04-23 |
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