FDA UDI
In Commercial Distribution
🇺🇸 United States
Silk Tape
DI: 00714196501226
·
Model: 501221
·
DERMARITE INDUSTRIES LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- Silk Tape
- Primary DI
- 00714196501226
- Version / Model
- 501221
- Company Name
- DERMARITE INDUSTRIES LLC
- Labeler DUNS
- 883925562
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2020-09-01
- Public Version
- 1
- Public Version Date
- 2020-09-09
- Public Version Status
- New
- Public Device Record Key
- be599e76-d29e-4380-bff6-90cb4821d1c3
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 34832 | Waterproof skin adhesive tape | A long and narrow flexible band that is coated on one side with a pressure-sensitive adhesive, and made from a material designed to resist water permeation, intended to be used to cover a surface (e.g., small wound), fix a dressing, attach objects, and/or exert pressure on a body part; it is not hypoallergenic. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00714196501226 | GS1 | ||||
| Unit of Use | 01714196501225 | GS1 |