FDA UDI
In Commercial Distribution
🇺🇸 United States
BENCO
DI: 00366975005489
·
Model: 5094-417
·
BENCO DENTAL SUPPLY CO.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- BENCO
- Primary DI
- 00366975005489
- Version / Model
- 5094-417
- Company Name
- BENCO DENTAL SUPPLY CO.
- Labeler DUNS
- 015108087
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-31
- Public Version
- 2
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- 2cb13d55-56f9-417a-b4bb-745e004707d0
Device Description
Spatula Wax #7A St. Louis
Device Characteristics
- Single Use
- No
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| GDZ | Handle, Scalpel | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38530 | Dental spatula, reusable | A hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00366975005489 | GS1 |
Customer Contacts
- Phone
- 570-602-6924
- [email protected]