| Primary Device ID | 25051978001321 |
| NIH Device Record Key | 6ac95d61-a883-434e-83b8-4b01a09dbf92 |
| Commercial Distribution Discontinuation | 2021-02-28 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIELLE® MAX |
| Version Model Number | MTP702 |
| Catalog Number | MTP702 |
| Company DUNS | 211352227 |
| Company Name | SYSTAGENIX WOUND MANAGEMENT, LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Width | 15 Centimeter |
| Length | 20 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051978001324 [Primary] |
| GS1 | 25051978001321 [Package] Contains: 15051978001324 Package: [5 Units] Discontinued: 2021-02-28 In Commercial Distribution |
| NAD | Dressing, Wound, Occlusive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
| 25051978001321 | Hydropolymer Non-Adhesive Dressing |
| 25051978001314 | Hydropolymer Non-Adhesive Dressing |
| 25051978001307 | Hydropolymer Non-Adhesive Dressing |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TIELLE 74688002 2022613 Live/Registered |
KCI USA, INC. 1995-06-14 |