Identity
- Trade Name
- Pasteur Pipette 3 mL FDA UDI
- Generic Name
- User-induced pipette FDA UDI
- Model / Reference
- 16202 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07350025914626 FDA UDI
- 510(k) Number
- K201213 FDA UDI
- FDA Product Code
- MQK FDA UDI
- GMDN Term
- User-induced pipette FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6160 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: User-induced pipette
Pasteur Pipette 3 mL by Vitrolife Sweden AB — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as User-induced pipette.
- KOVA — KOVA INTERNATIONAL INC · Class I
- Pumpmatic — ASHTON PUMPMATIC, INC. · Class I
- KOVA — KOVA INTERNATIONAL INC · Class I
- Pumpmatic — ASHTON PUMPMATIC, INC. · Class I
- KOVA — KOVA INTERNATIONAL INC · Class I
- Transfer pipette 3.5ml — Sarstedt Aktiengesellschaft & Co.KG · Class I
- KOVA — KOVA INTERNATIONAL INC · Class I
- IVF Pasteur Pipets — CooperSurgical, Inc. · Class II
Cleared under the same submission
K201213 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vitrolife Sweden AB
Sources (1)
- FDA UDI 539be8a0-7382-4d86-8947-8f67564bd38e 33 fields · synced May 30, 2026