FDA UDI
In Commercial Distribution
🇺🇸 United States
ZenFlex CM
DI: 00195062145773
·
Model: 818-3691
·
Kerr Corporation
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ZenFlex CM
- Primary DI
- 00195062145773
- Version / Model
- 818-3691
- Company Name
- Kerr Corporation
- Labeler DUNS
- 199354556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-19
- Public Version
- 1
- Public Version Date
- 2026-02-27
- Public Version Status
- New
- Public Device Record Key
- 91f4c845-8331-4c98-a042-5e935bbf306c
Device Description
ZenFlex CM .06/21mm ASSORTED PACK US/CAN Contents: .13/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145230, Qty 1 .15/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145261, Qty 1 .17/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145292, Qty 1 .20/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145322, Qty 1 .25/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145353, Qty 1 .30/.06/21mm ZenFlex CM NiTi FILE, GTIN 00195062145384, Qty 1
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|---|---|
| Primary | 00195062145773 | GS1 |
Customer Contacts
- Phone
- 1-800-537-7123
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Assorted sizes, Taper .06/Length 21mm |