| Primary Device ID | 00850144008178 |
| NIH Device Record Key | fc00b9ee-40bc-402d-b830-274c3974af52 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Pack Tyvek Pouch |
| Version Model Number | GUTP2040 |
| Catalog Number | 61301606741 |
| Company DUNS | 565751992 |
| Company Name | PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI |
| Device Count | 250 |
| 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 | true |
| Phone | 4196935300 |
| rdean@lexamed.net |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 35 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850144008178 [Primary] |
| GS1 | 10850144008175 [Package] Package: Case [4 Units] In Commercial Distribution |
| GS1 | 20850144008172 [Unit of Use] |
| FRG | Wrap, Sterilization |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-10-01 |
| 00850144008208 | Tyvek Pouch 30cm x 45cm |
| 00850144008192 | Tyvek Pouch 25cm x 45cm |
| 00850144008185 | Tyvek Pouch 25cm x 38cm |
| 00850144008178 | Tyvek Pouch 20cm x 40cm |
| 00850144008161 | Tyvek Pouch 20cm x 30cm |
| 00850144008154 | Tyvek Pouch 15cm x 30cm |
| 00850144008147 | Tyvek Pouch 10cm x 56cm |
| 00850144008130 | Tyvek Pouch 10cm x 30cm |