FDA UDI
In Commercial Distribution
🇺🇸 United States
DermaQuik
DI: 00853909006525
·
Model: Sport & Extreme 3 Multi-pouch
·
Dermaclip Us, L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- DermaQuik
- Primary DI
- 00853909006525
- Version / Model
- Sport & Extreme 3 Multi-pouch
- Catalog Number
- 62532
- Company Name
- Dermaclip Us, L.L.C.
- Labeler DUNS
- 043924405
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2023-04-20
- Public Version
- 1
- Public Version Date
- 2023-04-28
- Public Version Status
- New
- Public Device Record Key
- 10fe3933-f8f6-4b2b-b583-e7a824ac8da0
Device Description
DermaQuik Sport & Extreme, OTC, Enhanced Adhesive. 3 Packages in waterproof pouch. Each package contains 1 DermaQuik device which will close 1" of wound.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PYO | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32207 | Skin-closure adhesive strip | A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00853909006525 | GS1 | ||||
| Unit of Use | 00853909006297 | GS1 |
Customer Contacts
- Phone
- +1 (713) 682-3185
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Width | 21 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 85 Degrees Fahrenheit