FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroFrance®
DI: 10381780490296
·
Model: 110LP
·
INTEGRA LIFESCIENCES PRODUCTION CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroFrance®
- Primary DI
- 10381780490296
- Version / Model
- 110LP
- Catalog Number
- 110LP
- Company Name
- INTEGRA LIFESCIENCES PRODUCTION CORPORATION
- Labeler DUNS
- 081277700
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-09-14
- Public Version
- 2
- Public Version Date
- 2020-02-05
- Public Version Status
- Update
- Public Device Record Key
- 425bf583-5f92-48de-99e8-9fa009b3f6e1
Device Description
LOANER Pediatric Functional Endoscopic Sinus Surgery (FESS) Instrument Kit
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| OGR | Ear, nose, and throat surgical tray | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44067 | ENT surgical procedure kit, non-medicated, reusable | A collection of various ear/nose/throat (ENT) surgical instruments, dressings and the necessary materials used to perform an ENT surgical procedure. It does not contain pharmaceuticals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780490296 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]