FDA UDI
In Commercial Distribution
🇺🇸 United States
Siltape
DI: 05060031473308
·
Model: CR3938
·
BRIGHTWAKE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Siltape
- Primary DI
- 05060031473308
- Version / Model
- CR3938
- Company Name
- BRIGHTWAKE LIMITED
- Labeler DUNS
- 226502201
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-07-27
- Public Version
- 1
- Public Version Date
- 2023-08-04
- Public Version Status
- New
- Public Device Record Key
- d3f8628d-1522-4a74-9ac8-1e2d89de0b90
Device Description
Soft Silicone Perforated Tape, 2cm X 3m. Siltape is a soft silicone fixation tape delivered on a roll with perforations for ease of use. Siltape is made from Silicone that is gentler on removal unlike other adhesives that may cause tissue damage when removed and is particularly useful in patients with very thin, friable skin.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58749 | Dressing-fixation skin adhesive tape, silicone | A long and narrow flexible band of plastic, fabric or other material, with an adhesive layer made of soft silicone, designed to cover a surface (e.g., small wound), fix a dressing, or attach objects/devices to the body. The silicone layer is intended to be less allergenic and to allow for easy removal with less trauma to skin and less adhesion to bodily hair than conventional pressure-sensitive adhesives. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060031473322 | GS1 | Shipper | 12 | In Commercial Distribution | |
| Primary | 05060031473308 | GS1 |
Customer Contacts
- Phone
- +441623751151
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3 | Meter | |
| Width | 2 | Centimeter |