Identity
- Trade Name
- EndoGuidance L-Hook Electrode FDA UDI
- Generic Name
- Endoscopic electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- MDPL-33 L-Hook Monopolar Electrode 5x33mm FDA UDI
- Model / Reference
- MDPL-33 FDA UDI
- Description
- MDPL-33 L-Hook Monopolar Electrode 5x33mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810143451221 FDA UDI
- 510(k) Number
- K142208 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Endoscopic electrosurgical electrode, monopolar, 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
No
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
Category: Endoscopic electrosurgical electrode, monopolar, single-use
EndoGuidance L-Hook Electrode by Medical Disposables Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142208 also covers:
- EndoGuidance L-Hook Electrode — MEDICAL DISPOSABLES CORP
- EndoGuidance L-Hook Electrode — MEDICAL DISPOSABLES CORP
- MD EndoGuidance Laparoscopic Monopolar — MEDICAL DISPOSABLES CORP
- Surgical Direct — SURGICAL DIRECT, INC.
- Disposable Monopolar Atraumatic Intestinal Forceps — Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Disposable Monopolar Babcock Forceps — Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Disposable Monopolar Clinch Forceps — Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Disposable Monopolar Curved Scissors — Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Disposable Monopolar Dissector Forceps — Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Disposable Monopolar Grasper Forceps — Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Disposable Monopolar Mixter Forceps — Unimicro Medical Systems (ShenZhen) Co., Ltd.
- Disposable Monopolar Straight Scissors — Unimicro Medical Systems (ShenZhen) Co., Ltd.
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
- Medical Disposables Corp
Sources (1)
- FDA UDI 057a65df-75c7-44a4-ba48-7fa3ba375145 34 fields · synced May 30, 2026