FDA UDI
In Commercial Distribution
🇺🇸 United States
UC Strip™
DI: 10753567101204
·
Model: UC-20
·
Derma Sciences Canada Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- UC Strip™
- Primary DI
- 10753567101204
- Version / Model
- UC-20
- Catalog Number
- DERMA-UC20
- Company Name
- Derma Sciences Canada Inc
- Labeler DUNS
- 200564891
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2019-03-08
- Public Version
- 2
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- 54236703-c9b2-4608-b0ca-0db21dc72eb7
Device Description
UC Strip Catheter Tubing fastener
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
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| FPX | Strip, adhesive, closure, skin | 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 | 10753567101204 | GS1 | ||||
| Unit of Use | 00753567101207 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]