FDA UDI
In Commercial Distribution
🇺🇸 United States
NA
DI: 00849771047902
·
Model: General Instrument Pliers
·
KEY SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 00849771047902
- Version / Model
- General Instrument Pliers
- Catalog Number
- KI46578
- Company Name
- KEY SURGICAL, INC.
- Labeler DUNS
- 604056226
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-14
- Public Version
- 1
- Public Version Date
- 2023-08-22
- Public Version Status
- New
- Public Device Record Key
- 2e1e3c46-4795-4abd-948d-940080c88274
Device Description
German Stainless Steel Pliers, Pin Puller, 140mm with groove, Tungsten Carbide
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
- 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 |
|---|---|---|---|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38830 | Wire-extracting pliers | A manual surgical instrument specially designed to grip the end of a wire, typically the self-boring type, for its extraction from the patient's body. It has a scissors-like design with strong curved handles and short pointed jaws that are heavily serrated to grip the end of the wire for extraction. It is made of high-grade stainless steel and some types can have a threaded screw that the surgeon tightens which increases the pressure (the grip) on the jaws. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00849771047902 | GS1 | ||||
| Previous | 00849771011576 | GS1 |
Customer Contacts
- Phone
- +1(800)541-7995
- [email protected]