| Primary Device ID | D830500000091 |
| NIH Device Record Key | 48c49800-d82d-475c-bfe4-f21c6fd4df1a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Element Self Sealing Sterilization Pouch |
| Version Model Number | 500-00009 |
| Catalog Number | 500-00009 |
| 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 | false |
| 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 | true |
| Phone | 905.271.1523 |
| hamed@gsmedicalpackaging.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D830500000090 [Primary] |
| HIBCC | D830500000091 [Package] Contains: D830500000090 Package: Box [200 Units] In Commercial Distribution |
| HIBCC | D830500000092 [Package] Package: Case [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-06-16 |
| Device Publish Date | 2020-06-08 |
| D830500000112 | Self Sealing Sterilization Pouch 5.25’’ x 10” (13.3 cm x 25.4 cm) |
| D830500000102 | Self Sealing Sterilization Pouch Size: 3.5’’ x 10” (8.9cm x 25.4cm) |
| D830500000091 | Self Sealing Sterilization Pouch 2.75’’ x 10” |
| D83050000081 | Self Sealing Sterilization Pouch 3.5"X5.5" |