EndoEar™ SUCTION
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- EndoEar™ SUCTION SHORT CURVE, 20 GA, UP STAINLESS STEEL EUDAMEDEndoEar™ SUCTION FDA UDI
- Generic Name
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
- Device Name
- EndoEar™ SUCTION SHORT CURVE, 20 GA, UP STAINLESS STEEL FDA UDI
- Model / Reference
- 1.81.20 EUDAMEDFDA UDISuction Instrument EUDAMED
- Description
- EndoEar™ SUCTION SHORT CURVE, 20 GA, UP STAINLESS STEEL FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505012010 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445050023LG EUDAMED
- Direct Marketing DI
- 00844505012010 EUDAMED
- FDA Product Code
- JZF FDA UDI
- EMDN Code
- L14050199 MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Surgical/emergency suction cannula, non-illuminating, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 874.4420 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
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Surgical/emergency suction cannula, non-illuminating, reusable
EndoEar™ SUCTION by Grace Medical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/emergency suction cannula, non-illuminating, reusable.
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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
- Grace Medical, Inc.
Sources (2)
- FDA UDI bc779eb3-d594-4bbb-88fa-8ede32fddaa8 34 fields · synced Jul 11, 2026
- EUDAMED 842e19ea-97e5-48af-a03e-5c8f9cbcba6b 61 fields · synced Jul 11, 2026