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Suction Adapter, Rotatable 360°
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref 10-851-00CModel Suction Instrument
Identity
- Trade Name
- Suction Adapter Rotatable 360° EUDAMEDSUCTION ADAPTER, ROTATABLE 360° FDA UDI
- Generic Name
- ENT suction dissector FDA UDI
- Device Name
- SUCTION ADAPTER, ROTATABLE 360° FDA UDI
- Model / Reference
- 10-851-00C EUDAMEDFDA UDISuction Instrument EUDAMED
- Description
- SUCTION ADAPTER, ROTATABLE 360° FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00844505011365 EUDAMEDFDA UDI
- Basic UDI-DI
- 08445050023LG EUDAMED
- Direct Marketing DI
- 00844505011365 EUDAMED
- FDA Product Code
- LRC FDA UDI
- EMDN Code
- L14050199 MIDDLE EAR SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- ENT suction dissector 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
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: ENT suction dissector
Suction Adapter, Rotatable 360° by Grace Medical, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as ENT suction dissector.
- Adler Instrument Company — Adler, Inc. · Class I
- FENTEX — FENTEX medical GmbH · Class I
- Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
- Panetti ear drum suction dissector — Spiggle & Theis Medizintechnik GmbH · Class I
- OSSEOUS Suction Tube for Sinus-Disposable — EON MEDITECH PRIVATE LIMITED · Class I
- Medicon — Medicon eG. Chirurgiemechaniker-Genossenschaft · Class I
- PILLING — TELEFLEX INCORPORATED · Class I
- AESCULAP — AESCULAP, INC. · 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
- Grace Medical, Inc.
Sources (2)
- FDA UDI d52e228f-3382-4bf5-8f23-db5a41b9b1ba 34 fields · synced Jul 16, 2026
- EUDAMED 701e37ed-7bf9-459d-a961-534ab66d6e1c 61 fields · synced Jul 16, 2026