Identity
- Trade Name
- HOPKINS / SpineTIP FDA UDI
- Generic Name
- Rigid endoscope telescope FDA UDI
- Device Name
- Telescopes, channel EUDAMEDHOPKINS® Telescope 15°, 18 cm FDA UDI
- Model / Reference
- 28163FFA EUDAMEDFDA UDI
- Description
- HOPKINS® Telescope 15°, 18 cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04048551272749 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551000887US EUDAMED
- FDA Product Code
- HRX FDA UDI
- EMDN Code
- Z12029009 LAPAROSCOPES EUDAMED
- GMDN Term
- Rigid endoscope telescope FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 888.1100 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: Rigid endoscope telescope
HOPKINS / SpineTIP 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 6023bf14-ad21-4ac0-8ffb-6c4adacbb288 33 fields · synced Jun 19, 2026
- EUDAMED 8e5f06c0-7be5-462f-916e-43001060c9c9 61 fields · synced Jun 19, 2026