| Primary Device ID | 05060031476514 |
| NIH Device Record Key | fc197176-8a20-4b6d-aee3-75194a9f6c96 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Eclypse Foot |
| Version Model Number | CR4219 |
| Company DUNS | 226502201 |
| Company Name | BRIGHTWAKE 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 | false |
| OTC Over-The-Counter | false |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Width | 33 Centimeter |
| Length | 48 Centimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060031476507 [Primary] |
| GS1 | 05060031476514 [Package] Contains: 05060031476507 Package: Retail [5 Units] In Commercial Distribution |
| GS1 | 05060031476521 [Package] Package: Shipper [10 Units] In Commercial Distribution |
| NAC | Dressing, Wound, Hydrophilic |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-04 |
| Device Publish Date | 2023-07-27 |
| 05060031474107 - Activon Tulle | 2024-01-26 Knitted viscose mesh impregnated with 100% Manuka honey, 5cm x 5cm. Activon Tulle is a knitted viscose mesh primary dressing imp |
| 05060031475715 - Advazorb Border | 2024-01-25 Absorbent foam dressing with soft silicone wound contact layer and border, 20 cm X 20 cm. A self adherent absorbent dressing wit |
| 05060031470918 - Eclypse | 2023-08-04 Superabsorbent dressing, 15cm X 15cm. Eclypse is an exudate management wound dressing. The dressing combines a rapid wicking lay |
| 05060031470956 - Eclypse | 2023-08-04 Superabsorbent dressing, 20cm X 30cm. Eclypse is an exudate management wound dressing. The dressing combines a rapid wicking lay |
| 05060031471199 - Activon Tube | 2023-08-04 100% Medical Grade Manuka honey. Activon Tube contains 100% Medical Grade Manuka honey with no additives. This wound filler will |
| 05060031471267 - Eclypse | 2023-08-04 Superabsorbent dressing, 10cm X 10cm. Eclypse is an exudate management wound dressing. The dressing combines a rapid wicking lay |
| 05060031471434 - Eclypse | 2023-08-04 Superabsorbent dressing, 60cm X 40cm. Eclypse is an exudate management wound dressing. The dressing combines a rapid wicking lay |
| 05060031472431 - Eclypse Adherent | 2023-08-04 Superabsorbent dressing with Silfix soft silicone contact layer, 10cm X 10cm. Eclypse Adherent is an exudate management wound dr |