Identity
- Trade Name
- AESCULAP FDA UDI
- Generic Name
- Rigid optical intracranial/spinal endoscope, reusable FDA UDI
- Device Name
- REP.EXCH.MINOP SCOPE D:2.7MM 0°180MM FDA UDI
- Model / Reference
- PE184RE FDA UDI
- Description
- REP.EXCH.MINOP SCOPE D:2.7MM 0°180MM FDA UDI
Identifiers
- Catalog Number
- PE184RE FDA UDI
- Primary DI / UDI-DI
- 04038653416585 FDA UDI
- FDA Product Code
- GWG FDA UDI
- GMDN Term
- Rigid optical intracranial/spinal endoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.1480 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Rigid optical intracranial/spinal endoscope, reusable
Aesculap by Aesculap, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical intracranial/spinal endoscope, reusable.
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- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- ENDOCAMELEON — Karl Storz GmbH & Co. KG · Class II
- LOTTA — Karl Storz GmbH & Co. KG · Class II
- HOPKINS — Karl Storz GmbH & Co. KG · Class II
- QEVO — Carl Zeiss Meditec AG · Class II
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
- Aesculap, Inc.
Sources (1)
- FDA UDI b6519cf3-fc77-40b4-ad39-d01c3a3c4c4a 35 fields · synced Jun 8, 2026