| Primary Device ID | 00850144008345 |
| NIH Device Record Key | 08d09a44-f3b2-4419-863a-c8a8a0ec0cf1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Pack Sterilization Roll |
| Version Model Number | GUFL3030 |
| Catalog Number | 61301606750 |
| Company DUNS | 565751992 |
| Company Name | PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI |
| 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 | true |
| Phone | 4196935300 |
| rdean@lexamed.net |
| 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 | 00850144008345 [Primary] |
| GS1 | 00850144008352 [Package] Package: Case [2 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 | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-12-17 |
| 00850144008345 | Sterilization Roll 30cm x 30m |
| 00850144008321 | Sterilization Roll 23cm x 30m |
| 00850144008291 | Sterilization Roll 15cm x 30m |
| 10850144008267 | Sterilization Roll 10cm x 30m |
| 00850144008246 | Sterilization Roll 7.5cm x 30m |
| 00850144008215 | Sterilization Roll 5cm x 30m |