FDA UDI
In Commercial Distribution
🇺🇸 United States
OOCYTE RETRIEVAL NEEDLE 25CM G17
DI: 03700111401006
·
Model: OOCYTE RETRIEVAL NEEDLE 25CM G17
·
LABORATOIRE CCD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OOCYTE RETRIEVAL NEEDLE 25CM G17
- Primary DI
- 03700111401006
- Version / Model
- OOCYTE RETRIEVAL NEEDLE 25CM G17
- Catalog Number
- 1403002
- Company Name
- LABORATOIRE CCD
- Labeler DUNS
- 381633924
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-05
- Public Version
- 1
- Public Version Date
- 2023-12-13
- Public Version Status
- New
- Public Device Record Key
- df782b2c-e16d-42f4-a00a-fb16af15e674
Device Description
Needle for oocyte retrieval
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQE | NEEDLE, ASSISTED REPRODUCTION | Obstetrics/Gynecology | 884.6100 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45676 | IVF oocyte aspiration needle, single-use | A sterile, sharp bevel-edged, hollow tubular metal instrument specifically designed to penetrate ovarian follicles and aspirate oocytes (eggs) typically during the harvesting phase of an in vitro fertilization (IVF) procedure. The device may include aspiration tubing attached to its proximal end. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 03700111426009 | GS1 | Box | 10 | In Commercial Distribution | |
| Primary | 03700111401006 | GS1 |
Customer Contacts
- Phone
- +33(0)344266381
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Needle Gauge | 17 | Gauge | |
| Shaft Length | 25 | Centimeter |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- -The product must not be used in the event of damaged, or open primary packaging before the medical procedure. -Store away from direct sunlight. -Store in a dry place.