FDA UDI
In Commercial Distribution
🇺🇸 United States
KMEDIC
DI: 14026704722300
·
Model: IPN013646
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- KMEDIC
- Primary DI
- 14026704722300
- Version / Model
- IPN013646
- Catalog Number
- KM46184
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-02-16
- Public Version
- 1
- Public Version Date
- 2024-02-26
- Public Version Status
- New
- Public Device Record Key
- 7de292bf-40e5-49ad-bd72-6f242699e9ea
Device Description
CAST BREAKER WOLFF(BOEHLER) 9.5"
Device Characteristics
- Single Use
- No
- 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
- 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 |
|---|---|---|---|---|
| LGG | INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL | Orthopedic | 888.5980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46313 | Cast breaker | A manual surgical instrument with strong, curved blades used to grasp and break apart hardened plaster, i.e., that which has already been used to form a cast around a patient's limb or body part. It is designed like a large size forceps with curved serrated (serrated on the inside to provide grip) blades. These blades are prised between the body surface and the plaster cast and pressure is exerted upon the handles by squeezing them together to create a grip on the plaster that can then be broken off in pieces. It is typically made of high-grade stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 44026704722301 | GS1 | ||||
| Previous | 24026704268409 | GS1 | ||||
| Primary | 14026704722300 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 26.5 | Centimeter |