FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermapac, Inc.
DI: 10810102270792
·
Model: 6309
·
Dermapac Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Dermapac, Inc.
- Primary DI
- 10810102270792
- Version / Model
- 6309
- Company Name
- Dermapac Inc.
- Labeler DUNS
- 796088466
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-09-12
- Public Version
- 1
- Public Version Date
- 2022-09-20
- Public Version Status
- New
- Public Device Record Key
- fce14fc2-b91a-45b0-9376-b572c57f0c76
Device Description
Umbilical Tape 1/8" x 46"
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FTY | Tape, Measuring, Rulers And Calipers | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13983 | Umbilical cord tape | A thin, flat strip of synthetic and/or natural material which is used as a tie or suture around the umbilical cord of a newborn infant after severance from the placenta. It typically consists of a braided strip of cotton thread and or spun polyester yarn and comes in a variety of sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00810102270795 | GS1 | ||||
| Primary | 10810102270792 | GS1 |
Customer Contacts
- Phone
- 203-924-7148
- [email protected]