FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CONMED CLEARGUARD
DI: 10653405063261
·
Model: 000523
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
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Basic Information
- Brand Name
- CONMED CLEARGUARD
- Primary DI
- 10653405063261
- Version / Model
- 000523
- Catalog Number
- 000523
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2017-09-15
- Public Version
- 6
- Public Version Date
- 2026-03-25
- Public Version Status
- Update
- Public Device Record Key
- f1ed8b4f-3169-4101-af37-d0173801ec94
- Distribution End Date
- 2026-03-24
Device Description
CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR PENTAX GI ENDOSCOPES
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ODC | Endoscope channel accessory | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62145 | Endoscope working-channel valve, single-use | A device in the form of a small attachment intended to be fitted to the working channel (including biopsy port) of an endoscope to enable access for, and/or exchange of, an endoscopic device while minimizing leakage of liquids and gasses during an endoscopic procedure. Also referred to as a seal, it may be Luer formatted and include features to allow for simultaneous irrigation/biopsy or suction via the working channel. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20653405063268 | GS1 | CASE | 100 | Not in Commercial Distribution | 2026-03-24 |
| Primary | 10653405063261 | GS1 | ||||
| Unit of Use | 00653405063264 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090851 | 000 |