FDA UDI
In Commercial Distribution
🇺🇸 United States
TYDINGS TONSIL SNARE
DI: 00192896043961
·
Model: 485-720
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- TYDINGS TONSIL SNARE
- Primary DI
- 00192896043961
- Version / Model
- 485-720
- Catalog Number
- 485-720
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-17
- Public Version
- 1
- Public Version Date
- 2018-10-18
- Public Version Status
- New
- Public Device Record Key
- cc5ec839-c21e-4e53-9a92-3635884cb1a1
Device Description
TYDINGS TONSIL SNARE STRAIGHT TIP
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
- 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 |
|---|---|---|---|---|
| KBE | SNARE, NASAL | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 13632 | Tonsil snare | A manual surgical instrument inserted into the oral cavity to remove the tonsils during ear/nose/throat (ENT) surgery. It typically consists of a cannula-like tube with two stationary and one sliding finger rings designed to position and tighten a loop of thin, flexible wire (the snare) around the root of the tonsil to be removed. It is intended for mechanical cutting only (i.e., not through electrical ablation). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896043961 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]