FDA UDI
In Commercial Distribution
🇺🇸 United States
Reill TC Wire Cutter Forceps 21cm
DI: G25012298170
·
Model: 12-298-17
·
N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Reill TC Wire Cutter Forceps 21cm
- Primary DI
- G25012298170
- Version / Model
- 12-298-17
- Catalog Number
- 12-298-17
- Company Name
- N S SURGICAL COMPANY
- Labeler DUNS
- 645681649
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-04-28
- Public Version
- 1
- Public Version Date
- 2023-05-08
- Public Version Status
- New
- Public Device Record Key
- c70418eb-d66c-4e47-a5b6-0a58db1b62bb
Device Description
A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- ["Ethylene Oxide", "Moist Heat or Steam Sterilization", "Ultraviolet Light"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| HXZ | Cutter, Wire | Orthopedic | 888.4540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32885 | Wire cutter | A heavy-duty, hand-held manual surgical instrument with sturdy handles and blade-like jaws designed to cut orthopaedic wires, cerclages, and small diameter pins or bolts. It has a scissors-like lever action with straight or curved handles and is made of high-grade stainless steel. It is available in various sizes and the cutting blades (typically short, strong and with obtuse cutting edges) at the working end are activated through a single or double-jointed pivot that transfers the necessary shearing/cutting force. Commonly known as wire cutting pliers the blades can have a side or front cutting action; some may have carbide inserts for greater durability. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | G25012298170 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 17 | Centimeter |