Identity
- Trade Name
- ERBE FDA UDI
- Generic Name
- Water jet knife system handpiece, single-use FDA UDI
- Device Name
- Applicator w/ suction OD 6mm; L 65mm FDA UDI
- Model / Reference
- 20150-230 FDA UDI
- Description
- Applicator w/ suction OD 6mm; L 65mm FDA UDI
Identifiers
- Catalog Number
- 20150-230 FDA UDI
- Primary DI / UDI-DI
- 04050147001909 FDA UDI
- FDA Product Code
- FQH FDA UDI
- GMDN Term
- Water jet knife system handpiece, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 65.000 Millimeter FDA UDI
Category: Water jet knife system handpiece, single-use
Erbe by Erbe Elektromedizin GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Water jet knife system handpiece, single-use.
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- SpineJet® — HYDROCISION, INC. · Class II
- SpineJet® — HYDROCISION, INC. · Class II
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Cleared under the same submission
K072404 also covers:
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
K231023 also covers:
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
- ERBE — Erbe Elektromedizin GmbH
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 |
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Manufacturer
- Manufacturer
- Erbe Elektromedizin GmbH
Sources (1)
- FDA UDI 9a4927ac-aff0-4bdf-bfc4-21d1f3c06a98 38 fields · synced Jun 6, 2026