FDA UDI
In Commercial Distribution
🇺🇸 United States
DCTAPER
DI: D690SMPPPETHDCF1502
·
Model: U-200050
·
Ss White Burs, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- DCTAPER
- Primary DI
- D690SMPPPETHDCF1502
- Version / Model
- U-200050
- Catalog Number
- SMPPPETHDCF150
- Company Name
- Ss White Burs, Inc.
- Labeler DUNS
- 151760014
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-02-18
- Public Version
- 3
- Public Version Date
- 2025-05-07
- Public Version Status
- Update
- Public Device Record Key
- b2ada95e-c788-4a9f-8224-b2f28d273f9c
Device Description
SAMPLE/NON STERILE ETHDC F1 / SMPPPETHDCF1-50
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
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| EKN | POINT, PAPER, ENDODONTIC | Dental | 872.3830 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38777 | Endodontic paper point | A non-medicated absorbent point used in endodontic procedures that has been sterilized once in a manner approved by the manufacturer. 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 | D690SMPPPETHDCF1500 | HIBCC | ||||
| Primary | D690SMPPPETHDCF1502 | HIBCC |
Customer Contacts
- Phone
- +1(732)905-1100
- [email protected]