FDA UDI
In Commercial Distribution
🇺🇸 United States
Young
DI: 00302731776019
·
Model: 177601
·
YOUNG DENTAL MANUFACTURING I, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Young
- Primary DI
- 00302731776019
- Version / Model
- 177601
- Catalog Number
- 177601
- Company Name
- YOUNG DENTAL MANUFACTURING I, LLC
- Labeler DUNS
- 006309355
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-16
- Public Version
- 1
- Public Version Date
- 2022-10-24
- Public Version Status
- New
- Public Device Record Key
- 476eaa72-f2f8-43b1-8bc9-0ffb81012a51
Device Description
Young Rubber Damn Frame, Contoured Adult, Hooks, Balls, 7 tines,(5 1/16 in. X 4 1/8 in.) (12.8 cm x 10.4 cm)
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| EJE | FRAME, RUBBER DAM | Dental | 872.6300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31849 | Rubber dam frame | A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10302731776016 | GS1 | Box | 1 | In Commercial Distribution | |
| Primary | 00302731776019 | GS1 |
Customer Contacts
- Phone
- +1(800) 325-1881
- [email protected]