FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroFrance®
DI: 10381780103929
·
Model: MCEN81O
·
INTEGRA MICROFRANCE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroFrance®
- Primary DI
- 10381780103929
- Version / Model
- MCEN81O
- Catalog Number
- MCEN81O
- Company Name
- INTEGRA MICROFRANCE
- Labeler DUNS
- 276593071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-10-26
- Public Version
- 2
- Public Version Date
- 2023-05-15
- Public Version Status
- Update
- Public Device Record Key
- 0c5e99e0-333a-41af-ab1d-406afae762bc
Device Description
MicroFrance® Sleeve for Olympus telescope 30 °, 4 mm diameter
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| KCB | TUBE, TONSIL SUCTION | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58098 | Internally-anchored endoscopic retractor sleeve | A non-sterile, interchangeable, tubular device (sleeve) designed to be attached (screwed or snapped) to a dedicated applier and perform through a compatible endoscopic instrument (e.g., an access port) to insert an internally-anchored endoscopic retractor for hands-free retraction of a selected internal organ during a laparoscopic or thoracoscopic procedure. It is available in various diameters and lengths to accommodate various size internal retractors; after completion of the procedure it is used for extraction of the retractor. This is a reusable device intended to be sterilized prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780103929 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]