Identity
- Trade Name
- Suction irrigation sheath FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Model / Reference
- 191 401 771 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04059082029283 FDA UDI
- 510(k) Number
- K944656 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscope sheath, reusable
Suction irrigation sheath by SOPRO-COMEG GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Endoscope sheath, reusable.
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- B.I.O.H. — Karl Storz GmbH & Co. KG · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
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- SpineTIP — Karl Storz GmbH & Co. KG · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
Cleared under the same submission
K944656 also covers:
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- Integra® Jarit® — Integra LifeSciences Production Corporation
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- SINUSCOPE — PENTAX of America, Inc.
- Handle for sinuscope — SOPRO-COMEG GmbH
- Handle for sinuscope — SOPRO-COMEG GmbH
- Handle for sinuscope — SOPRO-COMEG GmbH
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
- SOPRO-COMEG GmbH
Sources (1)
- FDA UDI 30821d19-a7b4-40ca-9fa3-e758d269c321 33 fields · synced May 31, 2026