TIELLE® SACRUM MTL104
GUDID 25051978000621
Hydropolymer Adhesive Dressing
SYSTAGENIX WOUND MANAGEMENT, LIMITED
Exudate-absorbent dressing, non-gel| Primary Device ID | 25051978000621 |
| NIH Device Record Key | d4dacfa2-9f9b-4fb8-bd6c-21ac3ecc6d9a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TIELLE® SACRUM |
| Version Model Number | MTL104 |
| Catalog Number | MTL104 |
| 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 | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
| Width | 18 Centimeter |
| Length | 18 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 25 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15051978000624 [Primary] |
| GS1 | 25051978000621 [Package] Contains: 15051978000624 Package: [5 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 |
Devices Manufactured by SYSTAGENIX WOUND MANAGEMENT, LIMITED
| 25051978000539 - TIELLE® PACKING | 2020-05-06 Hydropolymer Dressing |
| 25051978001086 - FIBRACOL® PLUS | 2020-05-06 Collagen Wound Dressing with Alginate |
| 25051978001093 - FIBRACOL® PLUS | 2020-05-06 Collagen Wound Dressing with Alginate |
| 25051978001109 - FIBRACOL® PLUS | 2020-05-06 Collagen Wound Dressing with Alginate |
| 25051978001116 - FIBRACOL® PLUS | 2020-05-06 Collagen Wound Dressing with Alginate |
| 25051978002830 - PROMOGRAN PRISMA® | 2020-01-10 Matrix |
| 25051978002885 - PROMOGRAN PRISMA® | 2020-01-10 Matrix |
| 25051978009990 - PROMOGRAN PRISMA® | 2020-01-10 Matrix |
Trademark Results [TIELLE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TIELLE 74688002 2022613 Live/Registered |
KCI USA, INC. 1995-06-14 |
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