FDA UDI
In Commercial Distribution
🇺🇸 United States
Follicle Aspiration needle - single lumen
DI: 05425017505846
·
Model: #4551 FAS XD-BCB2
·
Gynetics Medical Products NV
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Follicle Aspiration needle - single lumen
- Primary DI
- 05425017505846
- Version / Model
- #4551 FAS XD-BCB2
- Company Name
- Gynetics Medical Products NV
- Labeler DUNS
- 283088573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-11-03
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 056c5d04-d074-49b0-ad70-6da00519a83e
Device Description
Transvaginal harvesting of oocytes from follicles for IVF and ICSI.
Device Characteristics
- Single Use
- Yes
- 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
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
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 | 25425017505840 | GS1 | 50 | In Commercial Distribution | ||
| Primary | 05425017505846 | GS1 | ||||
| Package | 15425017505843 | GS1 | 25 | In Commercial Distribution |
Customer Contacts
- Phone
- +3211645872
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K013497 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 0 – 30 Degrees Celsius