FDA UDI
In Commercial Distribution
🇺🇸 United States
Dermapac, Inc.
DI: 10810102270808
·
Model: 6367
·
Dermapac Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Dermapac, Inc.
- Primary DI
- 10810102270808
- Version / Model
- 6367
- Company Name
- Dermapac Inc.
- Labeler DUNS
- 796088466
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- 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
- 7701a9c1-980a-436f-9de1-7c29176c89ca
Device Description
3" Applicators wood handle 6/pk
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 |
|---|---|---|---|---|
| KXG | Applicator, Absorbent Tipped, Sterile | General Hospital | 880.6025 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33722 | General-purpose absorbent tip applicator/swab, single-use | A hand-held manual device, also known as a cotton bud or swab, in the form of a stick with a single- or double-ended absorbent tip (e.g., cotton pledget), intended for cleaning or applying a substance (e.g., medication) to a superficial wound or body orifice, and/or to take specimens from a patient. It is not dedicated to a particular body area or orifice, and is intended for use in a healthcare setting and/or in the home. 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 | 00810102270801 | GS1 | ||||
| Primary | 10810102270808 | GS1 |
Customer Contacts
- Phone
- 203-924-7148
- [email protected]