FDA UDI
In Commercial Distribution
🇺🇸 United States
Wexler Surgical, Inc.
DI: M944AL119010
·
Model: AL1190.1
·
WEXLER SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- Wexler Surgical, Inc.
- Primary DI
- M944AL119010
- Version / Model
- AL1190.1
- Company Name
- WEXLER SURGICAL, INC.
- Labeler DUNS
- 024882552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-26
- Public Version
- 3
- Public Version Date
- 2021-08-26
- Public Version Status
- Update
- Public Device Record Key
- 174ce21c-5fa7-433a-8b4a-baaf5b304ad6
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 |
|---|---|---|---|---|
| HOE | Caliper, Ophthalmic | Ophthalmic | 886.4350 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62517 | Chordae tendinae sizer | A sterile, hand-held manual surgical instrument intended to be used during mitral valve repair to determine the proper length of a chordal replacement prosthesis used to repair the chordae tendinae. It is a slender tool with a gauge and extendable distal hooks designed to measure the distance between the edge of the valve leaflet and the planned site of attachment of the chordal replacement to the papillary muscle. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M944AL119010 | HIBCC | ||||
| Secondary | 00840240900964 | GS1 |