FDA UDI
In Commercial Distribution
🇺🇸 United States
NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 50
DI: D77813011501
·
Model: 130-1150
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- NAVIFIL PLASTIC CARRIER OBTURATORS 5+1/pk # 50
- Primary DI
- D77813011501
- Version / Model
- 130-1150
- Catalog Number
- 130-1150
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- 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
- 25ac64b2-360f-4026-8cfb-1e98d6354a8c
Device Description
PLASTIC CARRIER OBTURATORS (6/pack) Contains: 5 obturators, 1 size verifier, Size: 50; For more information: https://www.scottsdental.com/catalog/product/view/id/31551/s/navifil-obturators/
Device Characteristics
- Single Use
- No
- 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 |
|---|---|---|---|---|
| EKK | SPREADER, PULP CANAL FILLING MATERIAL, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47751 | Warm-bonded endodontic obturation system obturator | A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. 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 | D77813011500 | HIBCC | ||||
| Primary | D77813011501 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]