FDA UDI
In Commercial Distribution
🇺🇸 United States
Mixing Tips
DI: E217172321
·
Model: 17232
·
Kettenbach GmbH & Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Mixing Tips
- Primary DI
- E217172321
- Version / Model
- 17232
- Catalog Number
- 17232
- Company Name
- Kettenbach GmbH & Co. KG
- Labeler DUNS
- 316803246
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-27
- Public Version
- 1
- Public Version Date
- 2018-12-28
- Public Version Status
- New
- Public Device Record Key
- 67b64bca-f0b2-484a-b13f-47035bac74d2
Device Description
Mixing Tips, brown, ø 2.5 mm
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EID | Syringe, Restorative And Impression Material | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58894 | Dental impression material syringe, single-use | A non-sterile, hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient?s mouth. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | E217172321 | HIBCC |
Customer Contacts
- Phone
- +4927747050
- [email protected]