Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Rigid endoscopic scissors, single-use FDA UDI
- Device Name
- 5mm 33cm Disposable Metzenbaum Scissors, Blue Rotator Knob, Curved with Monopolar Non-Locking – Single Use FDA UDI
- Model / Reference
- SD396989 FDA UDI
- Description
- 5mm 33cm Disposable Metzenbaum Scissors, Blue Rotator Knob, Curved with Monopolar Non-Locking – Single Use FDA UDI
Identifiers
- Catalog Number
- SD396989 FDA UDI
- Primary DI / UDI-DI
- B382SD3969890 FDA UDI
- 510(k) Number
- K142208 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Rigid endoscopic scissors, single-use 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid endoscopic scissors, single-use
Surgical Direct by Surgical Direct, Inc. — 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
- EndoGuidance L-Hook Electrode — MEDICAL DISPOSABLES CORP
- MD EndoGuidance Laparoscopic Monopolar — MEDICAL DISPOSABLES CORP
- 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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI a93eea80-655f-417e-be59-fb52a4dc65a0 36 fields · synced May 30, 2026