FDA UDI
In Commercial Distribution
🇺🇸 United States
SCOTT'S SELECT HEDSTROM FILES 6/pk 21mm # 45-80 ASST
DI: D77811241831
·
Model: 112-4183
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- SCOTT'S SELECT HEDSTROM FILES 6/pk 21mm # 45-80 ASST
- Primary DI
- D77811241831
- Version / Model
- 112-4183
- Catalog Number
- 112-4183
- 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
- 2c82ce14-f55f-4550-9f6b-28085fb43d01
Device Description
ENDODONTIC H-FILES (6/pack) Length: 21mm, Size: 45-80 (Assorted), Material: Stainless Steel; For more information: https://www.scottsdental.com/catalog/product/view/id/23540/s/hedstrom-files-21mm-scott-s-select/
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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKS | FILE, PULP CANAL, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63550 | Rotary/reciprocating endodontic file/rasp, single-use | A dental endpiece designed to be attached to a rotary or reciprocating dental power tool handpiece to debride and enlarge the root canal and smooth its walls by cutting or abrasion. It is made of metal [e.g., stainless steel, nickel-titanium alloy (Nitinol)] and its working end has a polygonal cross-section with edges. It may also be referred to as a rotary or engine file, or reamer. 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 | D77811241830 | HIBCC | ||||
| Primary | D77811241831 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]