FDA UDI
In Commercial Distribution
🇺🇸 United States
Defend
DI: 00840326406076
·
Model: TC-9001
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Defend
- Primary DI
- 00840326406076
- Version / Model
- TC-9001
- Catalog Number
- TC-9001
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-08
- Public Version
- 1
- Public Version Date
- 2022-11-16
- Public Version Status
- New
- Public Device Record Key
- c684879a-fe9b-4c2d-a430-2273e61f2133
Device Description
Tray Covers Paper. Rectangular. Disposable. Rounded Corners 8.5 inch x 12.25 inch | (21.6cm x 31.1cm) Blue
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
- 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 |
|---|---|---|---|---|
| NRD | Unit, operative dental, accessories | Dental | 872.6640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64367 | Instrument tray cover, single-use | A flexible, synthetic polymer cover designed to be placed on an instrument tray to provide a protective barrier for the transport and short-term storage of clinical instruments (typically endoscopes or surgical instruments). It is typically available in two colours to indicate clean/sterile or contaminated; a tray liner is typically supplied with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10840326406073 | GS1 | Box | 1000 | In Commercial Distribution | |
| Primary | 00840326406076 | GS1 |
Customer Contacts
- Phone
- +1 (800) 275-0020
- [email protected]