Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- 11mm Obturator with Safety Shield, Active Shielding, Lockable FDA UDI
- Model / Reference
- SD10479 FDA UDI
- Description
- 11mm Obturator with Safety Shield, Active Shielding, Lockable FDA UDI
Identifiers
- Catalog Number
- SD10479 FDA UDI
- Primary DI / UDI-DI
- B382SD104790 FDA UDI
- 510(k) Number
- K974382 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Endoscope sheath, 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
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
Dimensions & Sizes
- Size
- Outer Diameter — 11 Millimeter FDA UDI
Category: Endoscope sheath, reusable
Surgical Direct by Surgical Direct, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope sheath, reusable.
- Hermann Medizintechnik GmbH — Hermann Medizintechnik GmbH · Class I
- B.I.O.H. — Karl Storz GmbH & Co. KG · Class II
- SpineTIP — Karl Storz GmbH & Co. KG · Class II
- CONMED — Conmed Corporation · Class I
- Resectoscopy sheath — SOPRO-COMEG GmbH · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- CLICKLINE — Karl Storz GmbH & Co. KG · Class II
- Arthroscopy schaft — JOIMAX, INC. · Class I
Cleared under the same submission
K974382 also covers:
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Deluxe Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Mediflex Modular III Basic Laparoscopic Instruments — FLEXBAR MACHINE CORP.
- Hayden Medical — Hayden Medical Inc
- Hayden Medical — Hayden Medical Inc
- Novo Surgical — NOVO SURGICAL, 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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 44d4a112-38f9-4164-879b-9070b81db0e6 37 fields · synced May 30, 2026