FDA UDI
In Commercial Distribution
🇺🇸 United States
SPECTRUM
DI: D9098000231
·
Model: WIRE CUTTER
·
Ortho Arch Company Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SPECTRUM
- Primary DI
- D9098000231
- Version / Model
- WIRE CUTTER
- Catalog Number
- 800-023
- Company Name
- Ortho Arch Company Inc
- Labeler DUNS
- 020956330
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-17
- Public Version
- 1
- Public Version Date
- 2022-09-26
- Public Version Status
- New
- Public Device Record Key
- 88ff436b-504d-416f-92c1-c45b9ca78b6b
Device Description
SPECTRUM HARD WIRE CUTTER
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
- 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 |
|---|---|---|---|---|
| ECP | Instrument, Ligature Tucking, Orthodontic | Dental | 872.4565 | 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 | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D9098000231 | HIBCC |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- – 50 Degrees Celsius