TIELLE® NON ADHESIVE TLN1515EN
GUDID 25051978004667
Non Adhesive Hydropolymer Dressing
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Exudate-absorbent dressing, non-gel| Primary Device ID | 25051978004667 |
| NIH Device Record Key | bdcec153-08df-4f6d-96bc-6232422bf0f4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIELLE® NON ADHESIVE |
| Version Model Number | TLN1515EN |
| Catalog Number | TLN1515EN |
| 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 |
Device Dimensions
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
| Width | 15 Centimeter |
| Length | 15 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051978004660 [Primary] |
| GS1 | 25051978004667 [Package] Contains: 15051978004660 Package: [10 Units] In Commercial Distribution |
FDA Product Code
| NAD | Dressing, Wound, Occlusive |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-02 |
| Device Publish Date | 2019-09-24 |
On-Brand Devices [TIELLE® NON ADHESIVE]
| 25051978008290 | Non Adhesive Hydropolymer Dressing |
| 25051978004735 | Non Adhesive Hydropolymer Dressing |
| 25051978004704 | Non Adhesive Hydropolymer Dressing |
| 25051978004667 | Non Adhesive Hydropolymer Dressing |
| 25051978004605 | Non Adhesive Hydropolymer Dressing |
| 25051978004575 | Non Adhesive Hydropolymer Dressing |
Trademark Results [TIELLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIELLE 74688002 2022613 Live/Registered |
KCI USA, INC. 1995-06-14 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.