FDA UDI
Not in Commercial Distribution
🇺🇸 United States
CONMED CLEARGUARD
DI: 20653405063244
·
Model: 00522B
·
Conmed Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
400
Basic Information
- Brand Name
- CONMED CLEARGUARD
- Primary DI
- 20653405063244
- Version / Model
- 00522B
- Catalog Number
- 00522B
- Company Name
- Conmed Corporation
- Labeler DUNS
- 071595540
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 400
- Record Status
- Published
- Publish Date
- 2017-09-15
- Public Version
- 4
- Public Version Date
- 2021-06-01
- Public Version Status
- Update
- Public Device Record Key
- b1c2b075-5aae-4317-8b7e-eaa7fbe8ba98
- Distribution End Date
- 2021-05-30
Device Description
CONMED CLEARGUARD BIOPSY VALVES, DISPOSABLE BIOPSY VALVE FOR OLYMPUS AND FUJINON 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 |
|---|---|---|---|---|
| 47487 | Electrical-only medical device connection cable, reusable | A non-patient-contact, insulated, electrical cord with a connector (plug) at both ends designed to transmit electrical power and/or signal (data) between medical devices (e.g., to connect a lead, electrical catheter, handpiece, or monitor to a parent device). It is not intended to connect directly to patient-worn electrodes (i.e., it is not a lead), is not intended to connect to the mains (i.e., not a mains power cable), does not generate any type of power and/or signal, and has no additional non-electrical conducting or processing functionality. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10653405063247 | GS1 | CASE | 400 | Not in Commercial Distribution | 2020-10-21 |
| Primary | 20653405063244 | GS1 | ||||
| Unit of Use | 00653405063240 | GS1 |
Customer Contacts
- Phone
- +1(800)237-0169
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K090851 | 000 |