FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® MicroFrance®
DI: 10381780539285
·
Model: CEVA112
·
INTEGRA MICROFRANCE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® MicroFrance®
- Primary DI
- 10381780539285
- Version / Model
- CEVA112
- Catalog Number
- CEVA112
- 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
- 2
- Public Version Date
- 2024-10-28
- Public Version Status
- Update
- Public Device Record Key
- 36ca31b2-5f8f-4785-8f8d-6de11361c0a9
Device Description
Integra® MicroFrance® curved clamp, axial handle
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
- No
- 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 |
|---|---|---|---|---|
| GCJ | Laparoscope, general & plastic surgery | Gastroenterology, Urology | 876.1500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62468 | Surgical soft-tissue manipulation forceps, scissors-like, reusable | A hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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 | 10381780539285 | GS1 | ||||
| Previous | 10381780097600 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 10 | Millimeter | |
| Device Size Text, specify | 75 mm jaws | ||
| Length | 320 | Millimeter |