FDA UDI
In Commercial Distribution
🇺🇸 United States
Wexler Surgical, Inc.
DI: M944AL121210
·
Model: AL1212.1
·
WEXLER SURGICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Wexler Surgical, Inc.
- Primary DI
- M944AL121210
- Version / Model
- AL1212.1
- Company Name
- WEXLER SURGICAL, INC.
- Labeler DUNS
- 024882552
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-12-15
- Public Version
- 3
- Public Version Date
- 2021-10-29
- Public Version Status
- Update
- Public Device Record Key
- bce574e8-af67-4add-bbff-1e8db89b6b07
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 |
|---|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 870.4500 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35285 | Aorta punch, reusable | A manual surgical instrument designed to cut a circular plug of tissue from the wall of the aorta to create an anastomosis site during vascular surgery. It consists of a pointed, cone-shaped, disk-like tip on the end of a plunger that is inserted through a small incision made; its diameter corresponds to the size of the hole. Behind the tip is a thinner section which entraps (holds) the tissue as the sharp circular blade is pressed down the plunger by the surgeon into and through the tissue. It is typically made of high-grade stainless steel and is available in various punch sizes. It can equally be used to punch holes in other vessels if needed. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M944AL121210 | HIBCC | ||||
| Secondary | 00840240908090 | GS1 |