FDA UDI
In Commercial Distribution
🇺🇸 United States
Automix-Tips Blue 10:1
DI: EDMG1103511
·
Model: 110351
·
DMG Chemisch-Pharmazeutische Fabrik GmbH
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
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Basic Information
- Brand Name
- Automix-Tips Blue 10:1
- Primary DI
- EDMG1103511
- Version / Model
- 110351
- Catalog Number
- 110351
- Company Name
- DMG Chemisch-Pharmazeutische Fabrik GmbH
- Labeler DUNS
- 320744915
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2022-09-01
- Public Version
- 1
- Public Version Date
- 2022-09-09
- Public Version Status
- New
- Public Device Record Key
- f33cae0e-fe68-455c-b0a5-285e4626221b
Device Description
Automix-Tips Blue 10:1. Suitable for: Luxatemp Ultra, Luxatemp Fluorescence, Luxatemp Plus, Luxatemp Solar.
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
- Yes
- 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 |
|---|---|---|---|---|
| 60366 | Dental material injection cannula, single-use | A rigid or semi-rigid luminal device (dental tip) intended to channel and dispense a dental material/solution [e.g., restorative amalgam, resin, etching solution (etchant), topical dental anaesthetic] from a dental syringe, or similar applicator, to a patient’s teeth, oral mucosa, or gums; it is not intended to penetrate tissue (it is not a needle), not dedicated to root canal irrigation, and may be used for dental applications outside the patients 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 | EDMG1103511 | HIBCC | ||||
| Unit of Use | EDMG1103510 | HIBCC |
Customer Contacts
- Phone
- 201-894-5505
- [email protected]