FDA UDI
In Commercial Distribution
🇺🇸 United States
Defend
DI: 00843471127339
·
Model: CS-0200
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Defend
- Primary DI
- 00843471127339
- Version / Model
- CS-0200
- Catalog Number
- CS-0200
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-30
- Public Version
- 1
- Public Version Date
- 2022-11-07
- Public Version Status
- New
- Public Device Record Key
- fdd7aec9-a801-4c4f-9f45-08f8bf8dc80e
Device Description
Cotton Rolls Non-Sterile #2 Medium
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EFN | COTTON, ROLL | Dental | 872.6050 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31815 | Dental cotton roll | A non-sterile designed as an absorbent, non-sterile mass of cotton or man-made fibres formed as a small, short, hard-packed cylinder (a roll) that is used as a saliva absorber and intended to absorb moisture from the oral cavity during dental procedures. It may also be used as a packing between the lip/cheek and the gum to give better examination/operative exposure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20843471127333 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 10843471127336 | GS1 | Box | 2000 | In Commercial Distribution | |
| Primary | 00843471127339 | GS1 |
Customer Contacts
- Phone
- +1 (800) 275-0020
- [email protected]