| Primary Device ID | 00850144008512 | 
| NIH Device Record Key | 49d6df9f-5257-49ac-8c3b-3426a9aa3db6 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Getinge Pack Sterilization Pouch | 
| Version Model Number | GUFP1525 | 
| Catalog Number | 61301606756 | 
| 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 | 00850144008512 [Primary] | 
| GS1 | 00850144008529 [Package] Package: Case [4 Units] In Commercial Distribution | 
| GS1 | 00850144008536 [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 | 2018-01-19 | 
| 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 |