Identity
- Trade Name
- Needle Guide FDA UDI
- Generic Name
- Needle guide, single-use FDA UDI
- Device Name
- Sterile endocavity needle guide for use with GE Healtcare IC9 transducers. One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device. FDA UDI
- Model / Reference
- 842-002 FDA UDI
- Description
- Sterile endocavity needle guide for use with GE Healtcare IC9 transducers. One-cell MEA: =80% embryo developed to expand cytoblast at 96 hours USP Endotoxin (LAL) tested and passed with 20 EU or less per device. FDA UDI
Identifiers
- Catalog Number
- 842-002, 842-002-5 FDA UDI
- Primary DI / UDI-DI
- 10841436122228 FDA UDI
- 510(k) Number
- K231783 FDA UDI
- FDA Product Code
- MQE FDA UDIITX FDA UDI
- GMDN Term
- Needle guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.6100 FDA UDI892.1570 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
Yes
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
Ethylene Oxide FDA UDI
Category: Needle guide, single-use
Needle Guide by Civco Medical Instruments Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, single-use.
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Cleared under the same submission
K231783 also covers:
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., INC.
- Needle Guide — CIVCO MEDICAL INSTRUMENTS CO., 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 |
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Manufacturer
- Manufacturer
- Civco Medical Instruments Co., Inc.
Sources (1)
- FDA UDI 3e387abc-1a49-4789-bf03-b568c30a0ed2 37 fields · synced Jun 8, 2026