Identity
- Trade Name
- Klein FDA UDI
- Generic Name
- Electrical-only medical device connection cable, single-use FDA UDI
- Device Name
- Disposable 10ft. (3m) Monopolar Endoscopic Cord FDA UDI
- Model / Reference
- 3021-03 FDA UDI
- Description
- Disposable 10ft. (3m) Monopolar Endoscopic Cord FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841019110027 FDA UDI
- 510(k) Number
- K913514 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Electrical-only medical device connection cable, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
No
FDA UDI
Radiation Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Feet FDA UDI
Category: Electrical-only medical device connection cable, single-use
Klein by Klein Surgical Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Electrical-only medical device connection cable, single-use.
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- Symmetry Olsen — Olsen Medical · Class II
Cleared under the same submission
K913514 also covers:
- AESCULAP — AESCULAP, INC.
- Advanced Med-Surg Concepts — Advanced Med-Surg Concepts, Inc
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Kirwan — KIRWAN SURGICAL PRODUCTS LLC
- Klein Surgical — KLEIN SURGICAL SYSTEMS, INC.
- SOLOS — Solos Endoscopy, Inc.
- Surgical West — Surgical West, Inc.
- Walcott Rx — Walcott Rx Product 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
- Klein Surgical Systems, Inc.
Sources (1)
- FDA UDI a93de59a-82e8-479b-bea6-38b4dcb9d999 36 fields · synced May 31, 2026