Identity
- Trade Name
- Retractor Blade with handle, curved Lip EUDAMEDRetractor Blade FDA UDI
- Generic Name
- Hand-held endoscopic retractor, reusable FDA UDI
- Device Name
- Retractor Blade with handle, curved Lip EUDAMEDFDA UDI
- Model / Reference
- RB9583 EUDAMEDFDA UDI
- Description
- Retractor Blade with handle, curved Lip FDA UDI
Identifiers
- Catalog Number
- RB9583 FDA UDI
- Primary DI / UDI-DI
- 04250337120421 EUDAMEDFDA UDI
- Basic UDI-DI
- 42503371WOTURETXK EUDAMED
- Direct Marketing DI
- 04250337120421 EUDAMED
- FDA Product Code
- GDF FDA UDI
- EMDN Code
- L1199 NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Hand-held endoscopic retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 878.4800 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
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Hand-held endoscopic retractor, reusable
Retractor Blade by Joimax, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hand-held endoscopic retractor, reusable.
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- BOSS Instruments — Boss Instruments, Ltd. · Class I
- BOSS Instruments — Boss Instruments, Ltd. · Class I
- Symmetry Lowsley — SYMMETRY SURGICAL INC. · Class I
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Snowden-Pencer — STERIS CORPORATION · Class II
- BOSS Instruments — Boss Instruments, Ltd. · Class I
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 I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Joimax, Inc.
Sources (2)
- FDA UDI ef5e936a-54c8-4f01-b9e9-f4f48d00a16b 36 fields · synced Jun 19, 2026
- EUDAMED a1dd7e83-6515-410c-a164-b04c3d491f8e 61 fields · synced Jun 19, 2026