FDA UDI
In Commercial Distribution
🇺🇸 United States
Integra® MicroFrance®
DI: 10381780539162
·
Model: CEV7145A6
·
INTEGRA MICROFRANCE
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Integra® MicroFrance®
- Primary DI
- 10381780539162
- Version / Model
- CEV7145A6
- Catalog Number
- CEV7145A6
- 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
- bedb3579-48b5-44ba-83fa-39264b477110
Device Description
Integra® MicroFrance® Screw sleeve with stopcock for CEV7145A5 CEV7145A3 trocar tip
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 |
|---|---|---|---|---|
| HET | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Obstetrics/Gynecology | 884.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61424 | Laparoscopic trocar blade, reusable | A rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a separate laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Previous | 10381780095194 | GS1 | ||||
| Primary | 10381780539162 | GS1 |
Customer Contacts
- Phone
- +1(800)654-2873
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K993653 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 5 | Millimeter | |
| Length | 100 | Millimeter |