Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- 2.7mm Obturator, Sharp, 175mm WL FDA UDI
- Model / Reference
- SD826-08 FDA UDI
- Description
- 2.7mm Obturator, Sharp, 175mm WL FDA UDI
Identifiers
- Catalog Number
- SD826-08 FDA UDI
- Primary DI / UDI-DI
- B382SD826080 FDA UDI
- FDA Product Code
- NBH FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.1100 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
Yes
FDA UDI
Lot / Batch Number
No
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: Endoscope sheath, reusable
Surgical Direct by Surgical Direct, Inc. — Class I — 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
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 I | Pending data |
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Manufacturer
- Manufacturer
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 63e75109-1c77-442d-8d27-68ab06fc4851 35 fields · synced May 30, 2026