FDA UDI
In Commercial Distribution
🇺🇸 United States
FANOUS SABREBACK SCISSORS
DI: 00192896099593
·
Model: 1200-387
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- FANOUS SABREBACK SCISSORS
- Primary DI
- 00192896099593
- Version / Model
- 1200-387
- Catalog Number
- 1200-387
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-10
- Public Version
- 1
- Public Version Date
- 2019-10-18
- Public Version Status
- New
- Public Device Record Key
- a4e3ca09-1cc7-461f-b6b8-01ed14eb72e1
Device Description
FANOUS SABREBACK SCISSORS TENOTOMY CURVED POWER CUT GOLD BLADES
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
- Yes
- 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", "Dry Heat Sterilization"]
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KBD | Scissors, Nasal | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13495 | Nasal scissors | A hand-held, manual, surgical instrument used to cut tissue during ear/nose/throat (ENT) or plastic surgery in or on the nose and its associated structures. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes, usually having slender, pointed blades set at an angle to the handles. Some types can have carbide inserts along the cutting edges. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 00192896054882 | GS1 | ||||
| Primary | 00192896099593 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 6.5 | Inch |