Identity
- Trade Name
- TELE PACK FDA UDI
- Generic Name
- Endoscopic video image processing/light source system FDA UDI
- Device Name
- Combination devices EUDAMEDTELE PACK + FDA UDI
- Model / Reference
- TP101 EUDAMEDFDA UDI
- Description
- TELE PACK + FDA UDI
Identifiers
- Catalog Number
- TP101 FDA UDI
- Primary DI / UDI-DI
- 04048551425701 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551001578UH EUDAMED
- FDA Product Code
- FET FDA UDI
- EMDN Code
- Z12020403 MODULES FOR ENDOSCOPIC IMAGING AND MINIMALLY INVASIVE SURGERY EUDAMED
- GMDN Term
- Endoscopic video image processing/light source system 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
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Category: Endoscopic video image processing/light source system
Tele Pack by Karl Storz GmbH & Co. KG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 79323031-428e-42c3-bfa6-bb5f7c1a1276 35 fields · synced Jun 20, 2026
- EUDAMED 1fa11c7b-180b-43fc-be90-c8e1b00b4648 61 fields · synced Jun 20, 2026