Identity
- Trade Name
- EBERLE FDA UDI
- Generic Name
- Arthroscopic shaver system blade, reusable FDA UDI
- Device Name
- Meniscus Cutter 4,2 FDA UDI
- Model / Reference
- 9141242 FDA UDI
- Description
- Meniscus Cutter 4,2 FDA UDI
Identifiers
- Catalog Number
- 9141242 FDA UDI
- Primary DI / UDI-DI
- 04050052015893 FDA UDI
- 510(k) Number
- K092977 FDA UDI
- FDA Product Code
- HRX FDA UDI
- GMDN Term
- Arthroscopic shaver system blade, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.1100 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Arthroscopic shaver system blade, reusable
Eberle by Eberle GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Arthroscopic shaver system blade, reusable.
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class I
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class II
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class II
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class I
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class II
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class II
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class II
- REMA Shaver Blades — DEWIMED Medizintechnik GmbH · Class II
Cleared under the same submission
K092977 also covers:
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
- EBERLE — Eberle GmbH & Co. KG
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
- Eberle GmbH & Co. KG
Sources (1)
- FDA UDI 51be8e37-8b12-404a-88ae-dec0bbd6727e 35 fields · synced Jun 1, 2026