Identity
- Trade Name
- Gimmi FDA UDI
- Generic Name
- Endoscopic video imaging system FDA UDI
- Device Name
- ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL" FDA UDI
- Model / Reference
- S.2046.60 HD FDA UDI
- Description
- ALPHA MULTISTORE ACQUISITION BOX HD INCLUSIVE SOFTWARE "PERSONAL" FDA UDI
Identifiers
- Catalog Number
- S.2046.60 HD FDA UDI
- Primary DI / UDI-DI
- 04049047653516 FDA UDI
- FDA Product Code
- FET FDA UDI
- GMDN Term
- Endoscopic video imaging system 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Endoscopic video imaging system
Gimmi by Gimmi GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscopic video imaging system.
- NeedleView 0 Degree 65mm Scope Kit — BIOVISION TECHNOLOGIES, LLC · Class II
- NeedleView 30 Degree 100mm Scope Kit — BIOVISION TECHNOLOGIES, LLC · Class II
- KIT Danish 660HD-E IMS — Smith & Nephew, Inc. · Class I
- LENS — Smith & Nephew, Inc. · Class II
- InnerVue II 100mm Scope Kit — BIOVISION TECHNOLOGIES, LLC · Class II
- LENS — Smith & Nephew, Inc. · Class II
- Kit Portuguese 660HD-E IMS — Smith & Nephew, Inc. · Class I
- 660HD-E Image Management System — Smith & Nephew, 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gimmi GmbH
Sources (1)
- FDA UDI cf753144-9731-4907-83d1-da8452c173bd 35 fields · synced Jun 6, 2026