Identity
- Trade Name
- Cotton Plugged IVF Pasteur Pipets FDA UDI
- Generic Name
- User-induced pipette FDA UDI
- Device Name
- Origio, Inc. 9" (22.9 cm) Cotton Plugged IVF Pasteur Pipets FDA UDI
- Model / Reference
- PP-9-1000PL FDA UDI
- Description
- Origio, Inc. 9" (22.9 cm) Cotton Plugged IVF Pasteur Pipets FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50888937014100 FDA UDI
- 510(k) Number
- K000915 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
Cotton Plugged IVF Pasteur Pipets by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K000915 also covers:
- Cotton Plugged IVF Pasteur Pipets — CooperSurgical, Inc.
- Cotton Plugged IVF Pasteur Pipets — CooperSurgical, Inc.
- Cotton Plugged IVF Pasteur Pipets — CooperSurgical, Inc.
- IVF Pasteur Pipets — CooperSurgical, Inc.
- IVF Pasteur Pipets — CooperSurgical, Inc.
- IVF Pasteur Pipets — CooperSurgical, Inc.
- IVF Pasteur Pipets — CooperSurgical, Inc.
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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI b1cbb17d-33b1-448f-ade4-ba820c94acf4 34 fields · synced Jun 9, 2026