FDA UDI
In Commercial Distribution
🇺🇸 United States
Defend
DI: 00843471114148
·
Model: SL1956-F/SF
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Defend
- Primary DI
- 00843471114148
- Version / Model
- SL1956-F/SF
- Catalog Number
- SL1956-F/SF
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-23
- Public Version
- 2
- Public Version Date
- 2023-10-27
- Public Version Status
- Update
- Public Device Record Key
- 10bb3bc5-6884-4fc4-bb2c-5487f9b064dc
Device Description
COMPOSITE FINISHING AND POLISHING STRIPS REGULAR FINE/SUPER FINE 100 PACK
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
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EJL | Bur, Dental | Dental | 872.3240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35702 | Dental abrasive strip, single-use | A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843471114145 | GS1 | INNER PACK | 100 | In Commercial Distribution | |
| Primary | 00843471114148 | GS1 |
Customer Contacts
- Phone
- (800) 558-6684
- [email protected]