FDA UDI
In Commercial Distribution
🇺🇸 United States
DeRoyal
DI: 00749756265812
·
Model: 32-1521
·
DEROYAL INDUSTRIES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- DeRoyal
- Primary DI
- 00749756265812
- Version / Model
- 32-1521
- Catalog Number
- 32-1521
- Company Name
- DEROYAL INDUSTRIES, INC.
- Labeler DUNS
- 096372255
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-30
- Public Version
- 1
- Public Version Date
- 2021-07-08
- Public Version Status
- New
- Public Device Record Key
- f07e2d83-6d72-439d-9d42-98dd1eb337ac
Device Description
Custom Cotton Tipped Appplicators
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 50749756265817 | GS1 | Case | 2500 | In Commercial Distribution | |
| Primary | 00749756265812 | GS1 | ||||
| Package | 30749756265813 | GS1 | Box | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +1(888)938-7828
- [email protected]