FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: EYET7600017
·
Model: 760-0017
·
Yeti Dentalprodukte GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- EYET7600017
- Version / Model
- 760-0017
- Company Name
- Yeti Dentalprodukte GmbH
- Labeler DUNS
- 324001916
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-05-22
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- c97c61d1-b32f-4c70-aa00-9c4d58f9b33e
Device Description
CREATION Wax 6x8g light dentin
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EGD | WAX, DENTAL, INTRAORAL | Dental | 872.6890 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42879 | Denture clasp, metal, custom-made | A dental device made of metal, typically in wire form, intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet the specifications of an individual patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EYET7600017 | HIBCC |