FDA UDI
In Commercial Distribution
🇺🇸 United States
HyFlex EDM
DI: 14260614073606
·
Model: 60041084
·
Coltène/Whaledent GmbH + Co. KG
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
3
Basic Information
- Brand Name
- HyFlex EDM
- Primary DI
- 14260614073606
- Version / Model
- 60041084
- Catalog Number
- 60041084
- Company Name
- Coltène/Whaledent GmbH + Co. KG
- Labeler DUNS
- 315494443
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2025-10-22
- Public Version
- 1
- Public Version Date
- 2025-10-30
- Public Version Status
- New
- Public Device Record Key
- c43717be-d0d5-4d11-840f-0ef68a6b9db8
Device Description
HyFlex EDM 20/.05 Preparation File 31mm
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- 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 |
|---|---|---|---|---|
| 40529 | Rotary/reciprocating endodontic file/rasp, reusable | 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 reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 04260614073609 | GS1 | ||||
| Primary | 14260614073606 | GS1 |
Customer Contacts
- Phone
- + 4973458050
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- keep away from sunlight
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 25 Degrees Celsius
- Type
- Storage Environment Temperature
- Temperature Range
- 37 – 77 Degrees Fahrenheit