FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ENDOEYE FLEX LENS CLEANING SHEATH FOR 10MM
DI: 04953170353239
·
Model: OLYMPUS LC-S190-10-F
·
OLYMPUS MEDICAL SYSTEMS CORP.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- ENDOEYE FLEX LENS CLEANING SHEATH FOR 10MM
- Primary DI
- 04953170353239
- Version / Model
- OLYMPUS LC-S190-10-F
- Company Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Labeler DUNS
- 711789789
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-21
- Public Version
- 8
- Public Version Date
- 2022-08-15
- Public Version Status
- Update
- Public Device Record Key
- 534b3f8f-8a61-44f6-aba6-86d381921055
- Distribution End Date
- 2022-08-12
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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61204 | Endoscope lens cleaner, gas/fluid, single-use | A sterile device intended to be used for the in situ removal of fog/blood/debris from the lens of an endoscope (e.g., laparoscope), by directing gas and/or liquid to the edge of the lens. It is typically a multichannel sleeve with connection tubing. Gases/fluids are intended to be directed from a source through the channels within the sleeve to the lens. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 04953170353222 | GS1 | 5 | Not in Commercial Distribution | 2022-08-12 | |
| Primary | 04953170353239 | GS1 | ||||
| Package | 14953170353236 | GS1 | 1 | Not in Commercial Distribution | 2022-08-12 |
Customer Contacts
- Phone
- +1(800)401-1086
- [email protected]