FDA UDI
In Commercial Distribution
🇺🇸 United States
EN100 TL HANDLE
DI: 00192896088092
·
Model: Z-874.01.000
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- EN100 TL HANDLE
- Primary DI
- 00192896088092
- Version / Model
- Z-874.01.000
- Catalog Number
- Z-874.01.000
- 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
- 2
- Public Version Date
- 2026-03-05
- Public Version Status
- Update
- Public Device Record Key
- 2e7c968d-29f7-4b57-a643-dd2d50a6de4c
Device Description
EN100 TL HANDLE
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 |
|---|---|---|---|---|
| ETF | UNIT, EXAMINING/TREATMENT, ENT | Ear, Nose, Throat | 874.5300 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60353 | General physical examination set | A collection of hand-held devices, battery-powered but may include manual, intended to be used by a physician to help perform parts of a general physical examination of a patient [i.e., ear/nose/throat (ENT) and ophthalmic examinations, blood pressure measurements, temperature] commonly conducted in a primary care setting. The devices (e.g., aneroid sphygmomanometer, otoscope, ophthalmoscope, electronic thermometer) are typically housed within a line-powered charging station (e.g., desktop, wall-mounted) or carry case, which may include accessories (e.g., ear specula, spare light bulbs). This is a reusable device that may contain some disposable devices. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896088092 | GS1 |
Customer Contacts
- Phone
- +1(800)821-7496
- [email protected]