FDA UDI
In Commercial Distribution
🇺🇸 United States
FAST SPLINT MATRIX
DI: 00667147000227
·
Model: FSM18
·
Synca Marketing Inc
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- FAST SPLINT MATRIX
- Primary DI
- 00667147000227
- Version / Model
- FSM18
- Company Name
- Synca Marketing Inc
- Labeler DUNS
- 247111768
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-07-26
- Public Version
- 1
- Public Version Date
- 2021-08-03
- Public Version Status
- New
- Public Device Record Key
- bbc45ee0-680b-4a2b-ad81-3cb0c70363cb
Device Description
SILICONE WIDE APPLICATION TIPS (100)
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
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58498 | Dental material mixing nozzle, sterile | A sterile device designed for mixing inactive compounds during a dental/maxillofacial procedure to produce a functional dental restorative/impression/regenerative material which may be applied directly to the oral cavity/teeth of the patient or used for some other dental/maxillofacial 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 a certain number of 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 | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00667147100224 | GS1 | ||||
| Primary | 00667147000227 | GS1 |
Customer Contacts
- Phone
- 1-800-667-9622
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102207 | 000 |