FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Transfer Pipette
DI: 17350025912124
·
Model: 14344
·
Vitrolife Sweden AB
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Transfer Pipette
- Primary DI
- 17350025912124
- Version / Model
- 14344
- Company Name
- Vitrolife Sweden AB
- Labeler DUNS
- 631805488
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-09
- Public Version
- 4
- Public Version Date
- 2022-12-06
- Public Version Status
- Update
- Public Device Record Key
- 19c388b2-bf1d-436c-9b94-907f4c526c75
- Distribution End Date
- 2022-12-05
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MQH | Microtools, Assisted Reproduction (Pipettes) | Obstetrics/Gynecology | 884.6130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45410 | User-induced micropipette | A long, thin tube made of glass or plastic typically used in the laboratory for the manual withdrawal, transfer, and injection of minute volumes of fluid materials (e.g., microlitres or smaller). The user will typically attach a mouthpiece and create a partial vacuum within the device by gently sucking the air from inside the tube, inducing the substance to enter the device, or achieve the same action with a sqeezable bulb/syringe. Closing the mouthpiece or the user end of the pipette will hold the substance therein; dispensing is done by controlled venting of air into the user end or squeezing the bulb/syringe. Device use may include in vitro fertilization (IVF) procedures. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17350025912124 | GS1 | ||||
| Unit of Use | 07350025912127 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K991700 | 000 |