FDA UDI
In Commercial Distribution
🇺🇸 United States
SCOTT'S INFUSOR TIPS 100/bg w/ BRUSH-PADDED END
DI: D77819911251
·
Model: 199-1125
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- SCOTT'S INFUSOR TIPS 100/bg w/ BRUSH-PADDED END
- Primary DI
- D77819911251
- Version / Model
- 199-1125
- Catalog Number
- 199-1125
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2021-02-27
- Public Version
- 1
- Public Version Date
- 2021-03-08
- Public Version Status
- New
- Public Device Record Key
- d8b2f8a4-1f80-4746-8175-ae74d65477b4
Device Description
SCOTT'S INFUSOR TIPS 100/bg w/ BRUSH-PADDED END
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
- 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 |
|---|---|---|---|---|
| DZM | NEEDLE, DENTAL | Dental | 872.4730 | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | D77819911250 | HIBCC | ||||
| Primary | D77819911251 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]