FDA UDI
In Commercial Distribution
🇺🇸 United States
MicroFrance®
DI: 10381780104087
·
Model: MCO823
·
INTEGRA MICROFRANCE
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- MicroFrance®
- Primary DI
- 10381780104087
- Version / Model
- MCO823
- Catalog Number
- MCO823
- Company Name
- INTEGRA MICROFRANCE
- Labeler DUNS
- 276593071
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-01-12
- Public Version
- 3
- Public Version Date
- 2023-05-15
- Public Version Status
- Update
- Public Device Record Key
- df6e4d3f-afc9-4ab3-8aea-0d14b7ca26d6
Device Description
MicroFrance® Temporal bone specimen holder
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 |
|---|---|---|---|---|
| MXP | BONE PARTICLE COLLECTOR | Ear, Nose, Throat | 874.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 43956 | Temporal bone holder | A surgical device used to hold a piece of bone in a clamped position outside of the surgical field while the surgeon and/or other helping assistants work on it. It is typically used to reshape bone or for creating grafting material. This device will typically have a sturdy foot, a clamp to hold the bone, and an integral dish-like bowl to catch the bone fragments/cuttings. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10381780104087 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]