| Primary Device ID | D83050000081 |
| NIH Device Record Key | d9a98556-3dd4-4ae4-9548-b20dc6ed7344 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Element Self Sealing Sterilization Pouch |
| Version Model Number | 500-0008 |
| Catalog Number | 500-0008 |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8305000008 [Primary] |
| HIBCC | D83050000081 [Package] Contains: D8305000008 Package: BOX [200 Units] In Commercial Distribution |
| HIBCC | D83050000082 [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 | 2020-10-23 |
| Device Publish Date | 2020-10-15 |
| 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" |