Identity
- Trade Name
- EasyPass FDA UDI
- Generic Name
- Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Reusable Surgical Instruments EUDAMEDSuture Passers, Frog, 45° Right FDA UDI
- Model / Reference
- 801303100 EUDAMEDFDA UDI
- Description
- Suture Passers, Frog, 45° Right FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972884985688 EUDAMED06972884980966 FDA UDI
- Basic UDI-DI
- 69418325P2021036079B EUDAMED
- Direct Marketing DI
- 06972884985688 EUDAMED
- FDA Product Code
- HXI FDA UDI
- EMDN Code
- L1999 ARTHROSCOPIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Arthroscopic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 888.4540 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Category: Arthroscopic surgical procedure kit, non-medicated, reusable
EasyPass by Hangzhou Rejoin Mastin Medical Device Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Hangzhou Rejoin Mastin Medical Device Co., Ltd.
Sources (2)
- FDA UDI a9049d13-1a99-40f0-8d48-3f8a5b95e090 33 fields · synced Oct 6, 2026
- EUDAMED 2ebb619b-ff55-4a35-a4a5-34cf2d347409 61 fields · synced Jul 17, 2026