| Primary Device ID | 20814434020657 |
| NIH Device Record Key | 5b14ba44-189d-481d-a065-ce9e99593e74 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Pack Self-Seal Sterilization Pouch 14cm x 28cm |
| Version Model Number | 6005500045 |
| Catalog Number | 6005500045 |
| Company DUNS | 622223196 |
| Company Name | STERITEC PRODUCT MFG. CO., 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 | false |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00814434020653 [Primary] |
| GS1 | 10814434020650 [Package] Contains: 00814434020653 Package: Bag [200 Units] In Commercial Distribution |
| GS1 | 20814434020657 [Package] Contains: 10814434020650 Package: Case [14 Units] In Commercial Distribution |
| FRG | Wrap, Sterilization |
| 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 | 2016-09-23 |