Identity
- Trade Name
- VERSACRANE FDA UDI
- Generic Name
- Surgical instrument assist arm system, manually-adjusted FDA UDI
- Device Name
- Exoscope holding systems EUDAMEDVERSACRANE Holding Arm, low FDA UDI
- Model / Reference
- 28272GS EUDAMEDFDA UDI
- Description
- VERSACRANE Holding Arm, low FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551321560 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551001837UJ EUDAMED
- FDA Product Code
- OCV FDA UDI
- EMDN Code
- Z1201118099 INSTRUMENTS FOR OPERATIVE MICROSCOPY - HARDWARE ACCESSORIES - OTHER EUDAMED
- GMDN Term
- Surgical instrument assist arm system, manually-adjusted FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Surgical instrument assist arm system, manually-adjusted
Versacrane by Karl Storz GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical instrument assist arm system, manually-adjusted.
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Karl Storz GmbH & Co. KG
Sources (2)
- FDA UDI ce1fbfcf-60f0-4f59-8e4b-c50f23cd3e0c 33 fields · synced Jun 19, 2026
- EUDAMED 1eb6c80f-efa8-447f-89f2-c0462b2c6b09 61 fields · synced Jun 19, 2026