FDA UDI
In Commercial Distribution
🇺🇸 United States
HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUG
DI: 03700111400962
·
Model: HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUG
·
LABORATOIRE CCD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUG
- Primary DI
- 03700111400962
- Version / Model
- HOC2 A.R.T. OF C.C.D. ®WITH VALVE SOFT PLUG
- Catalog Number
- 1313601
- 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
- d1b900d8-2b2e-4c41-a936-c5ac2efb5fcd
Device Description
Set for oocyte retrieval
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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 | 03700111425965 | GS1 | Box | 5 | In Commercial Distribution | |
| Primary | 03700111400962 | GS1 |
Customer Contacts
- Phone
- +33(0)344266388
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Shaft Length | 30 | Centimeter | |
| Needle Gauge | 17 | Gauge |
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.