FDA UDI
In Commercial Distribution
🇺🇸 United States
Fischer Ultrapak Packer
DI: 00883205019769
·
Model: 174
·
ULTRADENT PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fischer Ultrapak Packer
- Primary DI
- 00883205019769
- Version / Model
- 174
- Catalog Number
- 174
- Company Name
- ULTRADENT PRODUCTS, INC.
- Labeler DUNS
- 013369913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-28
- Public Version
- 1
- Public Version Date
- 2018-05-29
- Public Version Status
- New
- Public Device Record Key
- c263ab2c-9036-4830-8a9f-1633d3e33c56
Device Description
Fischer's Ultrapak Packer 90° Small
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
- No
- 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 |
|---|---|---|---|---|
| EJB | HANDLE, INSTRUMENT, DENTAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31904 | Dental curette, basic | A hand-held dental instrument with a spoon-shaped working end designed to scrape oral tissues. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00883205019769 | GS1 |
Customer Contacts
- Phone
- +1(801)572-4200
- [email protected]