FDA UDI
In Commercial Distribution
🇺🇸 United States
BITE REG INTRAORAL TIP CD 96
DI: J014660009050
·
Model: 66000905
·
Kulzer GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
96
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Basic Information
- Brand Name
- BITE REG INTRAORAL TIP CD 96
- Primary DI
- J014660009050
- Version / Model
- 66000905
- Catalog Number
- 66000905
- Company Name
- Kulzer GmbH
- Labeler DUNS
- 315666321
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 96
- Record Status
- Published
- Publish Date
- 2024-09-09
- Public Version
- 2
- Public Version Date
- 2024-10-30
- Public Version Status
- Update
- Public Device Record Key
- ff2dd466-7077-42a9-bf74-188fac7510aa
Device Description
Syringe, Restorative and Impression Material
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
- Yes
- 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
- 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 |
|---|---|---|---|---|
| 58399 | Dental material mixing nozzle | A device designed for mixing inactive compounds during a dental procedure to produce a functional dental restorative/impression material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental application. It is nozzle-shaped and has an integral mixing mechanism (e.g., spiralled channels). It is attached to the end of a cartridge consisting of two tubes so that the compounds are mixed as they are expressed simultaneously from the tubes through the nozzle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | J014660009051 | HIBCC | ||||
| Primary | J014660009050 | HIBCC |
Customer Contacts
- Phone
- +1(800)431-1785
- [email protected]