FDA UDI
In Commercial Distribution
🇺🇸 United States
Wexler Surgical, Inc.
DI: M944CL800010
·
Model: CL8000.1
·
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
- M944CL800010
- Version / Model
- CL8000.1
- 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
- 7
- Public Version Date
- 2021-09-10
- Public Version Status
- Update
- Public Device Record Key
- 7c59bd2e-6d4a-41e4-b18c-4db6f6c4736d
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 |
|---|---|---|---|---|
| 65551 | Endoscope flushing adaptor, reusable | A small attachment designed to be fitted to an endoscope port for flushing of the endoscope’s lumen(s) during post-procedural washing, disinfection and/or sterilization. It is in the form of a plug that may include a button/switch for control of fluid (e.g., sterilant, disinfectant) and/or air through the lumen; it does not include tubing (i.e., not a tubing set). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | M944CL800010 | HIBCC | ||||
| Secondary | 00840240901336 | GS1 |