FDA UDI
In Commercial Distribution
🇺🇸 United States
ReadySteal Hedstrom File
DI: D71668540312
·
Model: 6854031
·
TULSA DENTAL PRODUCTS LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
6
Basic Information
- Brand Name
- ReadySteal Hedstrom File
- Primary DI
- D71668540312
- Version / Model
- 6854031
- Catalog Number
- 6854031
- Company Name
- TULSA DENTAL PRODUCTS LLC
- Labeler DUNS
- 942778564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 6
- Record Status
- Published
- Publish Date
- 2022-10-24
- Public Version
- 1
- Public Version Date
- 2022-11-01
- Public Version Status
- New
- Public Device Record Key
- 892d0d7a-767f-4f9c-8acf-06bbf7de84f7
Device Description
Ready Steal Hedstrom File Size 6854031 Length
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
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 |
|---|---|---|---|---|
| 63720 | Manual endodontic file/rasp, single-use | A hand-held manual dental instrument designed to debride and enlarge the root canal and smooth its walls by a cutting or abrasive action when moved in a longitudinal direction. 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 an endodontic 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 | D71668540311 | HIBCC | ||||
| Primary | D71668540312 | HIBCC |