FDA UDI
In Commercial Distribution
🇺🇸 United States
KMEDIC
DI: 24026704268331
·
Model: IPN013642
·
TELEFLEX INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- KMEDIC
- Primary DI
- 24026704268331
- Version / Model
- IPN013642
- Catalog Number
- KM46134
- Company Name
- TELEFLEX INCORPORATED
- Labeler DUNS
- 002348191
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-15
- Public Version
- 4
- Public Version Date
- 2026-02-05
- Public Version Status
- Update
- Public Device Record Key
- 8a20a8a0-9e75-496b-9609-f8032eef9b0b
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
- 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 |
|---|---|---|---|---|
| LGG | INSTRUMENT, CAST APPLICATION/REMOVAL, MANUAL | Orthopedic | 888.5980 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13708 | Cast spreader, reusable | A hand-operated instrument with specially designed blades intended to separate and spread hardened plaster, i.e., plaster that has already formed a cast around a patient's limb or body part. It is designed like large forceps with flat, outer-edge serrated blades that may be exchangeable and which are wedge-shaped (thin at the working end). The blades are intended to be prised between cut plaster so that when the device handles are squeezed the cast separates. 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 |
|---|---|---|---|---|---|---|
| Primary | 24026704268331 | GS1 | ||||
| Direct Marking | 04026704268337 | GS1 |
Customer Contacts
- Phone
- +1(919)544-8000
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 22.5 | Centimeter |