FDA UDI
In Commercial Distribution
🇺🇸 United States
Wexler Surgical, Inc.
DI: M944AL002430
·
Model: AL0024.3
·
WEXLER SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Wexler Surgical, Inc.
- Primary DI
- M944AL002430
- Version / Model
- AL0024.3
- Company Name
- WEXLER SURGICAL, INC.
- Labeler DUNS
- 024882552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-14
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 480cb750-5955-44ad-a0ea-5aa41854bd00
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 |
|---|---|---|---|---|
| HNQ | Hook, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62923 | Lens nucleus manipulator | A hand-held, manual, ophthalmic surgical instrument intended to be used to rotate/manipulate the natural lens nucleus, typically during ultrasonic emulsification prior to aspiration in preparation for intraocular lens implantation. It has a probe-like form, typically with a Y-shaped tip mounted on a handle, and is made of high-grade stainless steel. This is a reusable device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M944AL002430 | HIBCC |