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DuploSpray MIS
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 0600043Ref 0600134Ref 0600033Ref 0601130Ref 0601133Ref 0600044Ref 0600029Ref 0601129Ref 0600031
Identity
- Trade Name
- DuploSpray MIS EUDAMEDDuploSpray MIS Regulator EUDAMEDDuploSpray EUDAMEDFDA UDIBaxter FDA UDI
- Generic Name
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDIFibrin sealant biochemical preparation/application kit, endoscopic FDA UDI
- Device Name
- DuploSpray MIS Applicator EUDAMEDRegulator EUDAMEDDuploSpray MIS Applicator with Snap Lock, 20cm FDA UDIDuploSpray MIS Applicator, Coseal 20cm FDA UDI
- Model / Reference
- 0600043 EUDAMEDFDA UDI0600134 EUDAMED0600033 EUDAMED0601130 EUDAMED0601133 EUDAMEDFDA UDI0600044 EUDAMED0600029 EUDAMED0601129 EUDAMED0600031 EUDAMED
- Description
- DuploSpray MIS Applicator with Snap Lock, 20cm FDA UDIDuploSpray MIS Applicator, Coseal 20cm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815634020792 EUDAMED10815634020853 EUDAMED10815634020662 EUDAMED20815634020591 EUDAMED20815634020799 EUDAMED10815634020570 EUDAMED00815634020573 EUDAMEDFDA UDI00815634020795 EUDAMEDFDA UDI20815634020812 EUDAMED20815634020645 EUDAMED10815634020587 EUDAMED20815634020669 EUDAMED20815634020577 EUDAMED10815634020211 EUDAMED
- Basic UDI-DI
- B-10815634020792 EUDAMEDB-10815634020853 EUDAMEDB-10815634020662 EUDAMEDB-20815634020591 EUDAMEDB-20815634020799 EUDAMEDB-10815634020570 EUDAMEDB-00815634020795 EUDAMEDB-20815634020812 EUDAMEDB-20815634020645 EUDAMEDB-10815634020587 EUDAMEDB-20815634020669 EUDAMEDB-00815634020573 EUDAMEDB-20815634020577 EUDAMEDB-10815634020211 EUDAMED
- 510(k) Number
- K061092 FDA UDI
- FDA Product Code
- FMF FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMEDA030104 FLOW REGULATORS EUDAMED
- GMDN Term
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDIFibrin 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
- Not in Commercial Distribution FDA UDIIn Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDIEUDAMED
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
EUDAMEDEUDAMED
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
DuploSpray MIS 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-10815634020792 | 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 (16)
- EUDAMED 40c8a954-b15c-41ad-92e3-006e67b75371 61 fields · synced Jul 23, 2026
- EUDAMED 8cd6308d-49fa-4cf1-96e1-97f179b2daf1 61 fields · synced May 11, 2026
- EUDAMED db2f0827-277e-4741-9392-32a4a5549be0 61 fields · synced May 11, 2026
- EUDAMED 6e38226b-4cf1-4f61-ae33-93b2cd30f389 61 fields · synced May 16, 2026
- EUDAMED 346cc6f2-8ca4-4123-bb88-24c40321c581 61 fields · synced May 17, 2026
- EUDAMED 07c8497b-0aa7-4fca-9f3f-f13be1a58ba8 61 fields · synced May 18, 2026
- FDA UDI 67876642-9934-439b-815a-b66da6162377 35 fields · synced May 29, 2026
- FDA UDI 4d248270-e727-4cf1-a60f-e21e7e16cd15 33 fields · synced May 30, 2026
- EUDAMED 5176b1e8-695d-47ab-b056-743135abf4a1 61 fields · synced Jul 8, 2026
- EUDAMED dfbb7c21-6302-4fa8-9013-0a854af1624b 61 fields · synced Jul 9, 2026
- EUDAMED 423c9db7-5d74-4fd1-a8e4-167aa5d355e8 61 fields · synced Jul 9, 2026
- EUDAMED 95201647-017d-4d79-a4fd-b37de80e4dc7 61 fields · synced Jul 9, 2026
- EUDAMED 07967d8a-6240-42d9-92cf-36fa8e253328 61 fields · synced Jul 12, 2026
- EUDAMED 0da36a08-c762-42c8-81a7-d3ad5ffcf60a 61 fields · synced Jul 12, 2026
- EUDAMED 5199bc26-2d2f-47a9-b5d4-f84312a203fc 61 fields · synced Jul 12, 2026
- EUDAMED 03592cfb-01d5-4920-8a86-1cef5e996293 61 fields · synced Jul 13, 2026