| Primary Device ID | 14048223020941 |
| NIH Device Record Key | 8eec02a4-9227-4391-8b33-d41021d53601 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EcoBalloonDuo DIL-BI + URO |
| Version Model Number | 1285-50-28S |
| Catalog Number | 1285-50-28S |
| Company DUNS | 317654283 |
| Company Name | Pajunk GmbH Medizintechnologie |
| Device Count | 5 |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com | |
| Phone | +1(888)972-5865 |
| info@pajunk-usa.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04048223020944 [Unit of Use] |
| GS1 | 14048223020941 [Primary] |
| GCJ | Laparoscope, general & plastic surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-24 |
| Device Publish Date | 2019-04-16 |
| 14048223020941 | EcoBalloonDuo DIL-BI + URO Bilateral double balloon set Ø 11mm for extraperi |
| 04048223133163 | EcoBalloonDuo DIL-BI + URO Bilateral double balloon set Ø 11mm for extraperitoneal surgery, |