FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermapac, Inc.
DI: 10810102271164
·
Model: 8211
·
Dermapac Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Dermapac, Inc.
- Primary DI
- 10810102271164
- Version / Model
- 8211
- 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
- 4f6ee71c-2b89-4cd2-9467-6cad702951f4
Device Description
Measuring Tape 24"
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 |
|---|---|---|---|---|
| 44866 | Wound measure | A device designed to determine the dimensions of a wound typically to document changes in wound size during the healing process. The device may be a simple ruler or similar measuring device and/or a tracing film to outline a wound that may utilize an electronic digital tablet to calculate wound area or other dimensions (e.g., length, width, depth). 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 | 00810102271167 | GS1 | ||||
| Primary | 10810102271164 | GS1 |
Customer Contacts
- Phone
- 203-924-7148
- [email protected]