Identity
- Trade Name
- GEMINI FDA UDI
- Generic Name
- Electrical-only medical device connection cable, reusable FDA UDI
- Device Name
- LIGHT CABLE 2MM X 8FT FDA UDI
- Model / Reference
- 3004 FDA UDI
- Description
- LIGHT CABLE 2MM X 8FT FDA UDI
Identifiers
- Catalog Number
- 3004 FDA UDI
- Primary DI / UDI-DI
- 03596010113702 FDA UDI
- 510(k) Number
- K914919 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrical-only medical device connection cable, reusable
Gemini by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electrical-only medical device connection cable, reusable.
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Guenter Bissinger Medizintechnik GmbH — Günter Bissinger Medizintechnik GmbH · Class II
- Unimed — Unimed Medical Supplies, Inc. · Class II
- Symmetry Olsen — Olsen Medical · Class II
- Connection Cable — Shenzhen Keborui Electronics Co., Ltd · Class I
- TC-HEART LUNG DIN INTFC CA STOCKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD. · Class II
- MICTEC CONNECTION CABLE — SONTEC INSTRUMENTS, INC. · Class II
- ECG Cable — Edan Instruments,Inc. · Class I
Cleared under the same submission
K914919 also covers:
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- GEMINI — Smith & Nephew, Inc.
- LIGHT GUIDE — Smith & Nephew, Inc.
- LIGHT GUIDE — Smith & Nephew, Inc.
- STORZ — Smith & Nephew, Inc.
- VERSITIP — Smith & Nephew, Inc.
- VERSITIP — Smith & Nephew, Inc.
- VERSITIP — Smith & Nephew, Inc.
- VERSITIP — Smith & Nephew, 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
- Smith & Nephew, Inc.
Sources (1)
- FDA UDI 17ed1adc-f9bd-4b9c-b63e-32714c4e024e 36 fields · synced Jun 8, 2026