| Primary Device ID | 00857180007639 |
| NIH Device Record Key | 009e3eee-be27-4ebf-9333-558620ab9ba8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Viscera Retainer Radiopaque Center Spine |
| Version Model Number | Large |
| Catalog Number | RMD3206 |
| Company DUNS | 116723413 |
| Company Name | RAINBOW MEDICAL DEVICES LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 8474772074 |
| deanstockwell@sbcglobal.net |
| Height | 9.5 Inch |
| Height | 9.5 Inch |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00857180007615 [Primary] |
| GS1 | 00857180007622 [Package] Contains: 00857180007615 Package: Corrugate box [10 Units] In Commercial Distribution |
| GS1 | 00857180007639 [Package] Contains: 00857180007615 Package: Corrugate box [150 Units] In Commercial Distribution |
| GCZ | Retainer, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-15 |
| Device Publish Date | 2019-01-15 |
| 00857180007738 | One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. |
| 00857180007639 | One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. |
| 00857180007431 | One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. |
| 00857180007233 | One unit packaged in a Poly/Poly Chevron sealed pouch, Gama Sterilized with a 3 year shelf life. |