| Primary Device ID | D8304421011 |
| NIH Device Record Key | 595a4809-ef85-475b-8747-f36e72bbde09 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Professional's Choice |
| Version Model Number | 442101 |
| Company DUNS | 246113039 |
| Company Name | GS Medical Packaging Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D830442101 [Primary] |
| HIBCC | D8304421011 [Package] Contains: D830442101 Package: cardboard box [200 Units] In Commercial Distribution |
| HIBCC | D8304421012 [Package] Package: cardboard box [6 Units] In Commercial Distribution |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2016-10-06 |