FDA UDI
In Commercial Distribution
🇺🇸 United States
LIEBERMAN SPECULUM
DI: 00192896012103
·
Model: T10-1748
·
SONTEC INSTRUMENTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIEBERMAN SPECULUM
- Primary DI
- 00192896012103
- Version / Model
- T10-1748
- Catalog Number
- T10-1748
- Company Name
- SONTEC INSTRUMENTS, INC.
- Labeler DUNS
- 040729840
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-18
- Public Version
- 2
- Public Version Date
- 2019-05-15
- Public Version Status
- Update
- Public Device Record Key
- 19e77005-fe73-4ecd-b63d-1181c4a839ae
Device Description
LIEBERMAN SPECULUM TEMPORAL APPROACH CURVED EXTENDED ARM BLADES TITANIUM
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 |
|---|---|---|---|---|
| HNC | Specula, ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35349 | Eyelid speculum, reusable | A self-retaining, ophthalmic surgical instrument intended to be used to retract the eyelids during an opthalmologic examination or procedure. It is typically composed of two arms joined at a pivot point and that terminate in blunt tips; the arms can be expanded with a self-opening or adjustable mechanism to stretch tissue. The device is available in various sizes, shapes, and contours and is usually made of stainless steel. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00192896012103 | GS1 |
Customer Contacts
- Phone
- +1(800) 821-7496
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 13 Millimeter Blades |