| Primary Device ID | 00850144008680 |
| NIH Device Record Key | 0b8194ec-fd0c-4eeb-b76b-efdda71d5409 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Getinge Pack Sterilization Pouch |
| Version Model Number | GUFP3045 |
| Catalog Number | 61301606762 |
| 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 | 00850144008680 [Primary] |
| GS1 | 00850144008697 [Package] Package: Case [4 Units] In Commercial Distribution |
| GS1 | 00850144008703 [Unit of Use] |
| JOJ | Indicator, Physical/Chemical Sterilization Process |
| 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 | 2018-01-20 |
| 00850144008710 | Sterilization Pouch 40cm x 40cm |
| 00850144008680 | Sterilization Pouch 30cm x 45cm |
| 00850144008659 | Sterilization Pouch 30cm x 30cm |
| 00850144008628 | Sterilization Pouch 25cm x 38cm |
| 00850144008598 | Sterilization Pouch 20cm x 40cm |
| 00850144008567 | Sterilization Pouch 20cm x 25cm |
| 00850144008543 | Sterilization Pouch 20cm x 33cm |
| 00850144008512 | Sterilization Pouch 15cm x 25cm |
| 00850144008482 | Sterilization Pouch 13cm x 38cm |
| 00850144008468 | Sterilization Pouch 10cm x 56cm |
| 00850144008437 | Sterilization Pouch 10cm x 30cm |
| 00850144008406 | Sterilization Pouch 10cm x 20cm |
| 00850144008376 | Sterilization Pouch 7.5cm x 20cm |