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Spray Set 360 Endoscopic Applicator with Snap Lock
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0611128
Identity
- Trade Name
- Spray Set 360 Endoscopic Applicator with Snap Lock EUDAMEDBaxter FDA UDI
- Generic Name
- Fibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
- Device Name
- Spray Set 360 Endoscopic Applicator with Snap Lock EUDAMEDFDA UDI
- Model / Reference
- 0611128 EUDAMEDFDA UDI
- Description
- Spray Set 360 Endoscopic Applicator with snap lock FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634020610 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00815634020610 EUDAMED
- 510(k) Number
- K061092 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Fibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.5860 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Spray Set 360 Endoscopic Applicator with Snap Lock by Micromedics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00815634020610 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Micromedics, Inc.
- EUDAMED SRN
- US-MF-000018365
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 00f38bf9-4ba5-4c33-94c8-b9158e1d7c23 61 fields · synced Jun 18, 2026
- FDA UDI 2f11cb29-2c1b-40dd-b484-8d2971304160 34 fields · synced May 30, 2026