Identity
- Trade Name
- HOPKINS FDA UDI
- Generic Name
- Hand-held surgical retractor, reusable FDA UDI
- Device Name
- Telescopes, laryngoscopy EUDAMEDTele-Laryngoscope 70°, 5.8 mm FDA UDI
- Model / Reference
- 8700CKA EUDAMEDFDA UDI
- Description
- Tele-Laryngoscope 70°, 5.8 mm FDA UDI
Identifiers
- Catalog Number
- 8700CKA FDA UDI
- Primary DI / UDI-DI
- 04048551216422 EUDAMEDFDA UDI
- Basic UDI-DI
- 4048551001554U3 EUDAMED
- FDA Product Code
- EOB FDA UDI
- EMDN Code
- Z12021003 LARYNGOSCOPES EUDAMED
- GMDN Term
- Hand-held surgical retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 874.4760 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: Hand-held surgical retractor, reusable
Hopkins 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 d58f3d9a-3ef5-4e16-9486-15ab76e3ad53 35 fields · synced Jun 19, 2026
- EUDAMED 9fc320fe-0eab-49e9-b38e-3730341d06b9 61 fields · synced Jun 19, 2026