FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroFrance®
DI: 10381780539971
·
Model: MCL291
·
INTEGRA MICROFRANCE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- MicroFrance®
- Primary DI
- 10381780539971
- Version / Model
- MCL291
- Catalog Number
- MCL291
- Company Name
- INTEGRA MICROFRANCE
- Labeler DUNS
- 276593071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-29
- Public Version
- 1
- Public Version Date
- 2024-06-06
- Public Version Status
- New
- Public Device Record Key
- a74f0af0-04e3-4a88-8642-fb9a3eba54eb
Device Description
MicroFrance® Abitbol left suction tube for laryngoscope MCL291
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 |
|---|---|---|---|---|
| CCW | LARYNGOSCOPE, RIGID | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43946 | Rigid optical laryngopharyngoscope | An endoscope with a rigid inserted portion intended for the visual examination and treatment of the larynx/oropharynx. It is inserted into the body through the mouth during ear/nose/throat (ENT) procedures. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle, or the device may allow for direct visualization through the lumen of its shaft/working channel. This device may be equipped with a channel or mechanism allowing the introduction of air to prevent misting of the distal end. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 10381780105404 | GS1 | ||||
| Primary | 10381780539971 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]