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Baxter Gasless Tip Applicator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 601156Ref 601159Ref 601158
Identity
- Trade Name
- Baxter Gasless Tip Applicator EUDAMEDNordson Medical FDA UDI
- Generic Name
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
- Device Name
- Gasless Tip Applicator EUDAMEDGasless Applicator 40CM, OUS - Baxter FDA UDI
- Model / Reference
- 601156 EUDAMED601159 EUDAMEDFDA UDI601158 EUDAMED
- Description
- Gasless Applicator 40CM, OUS - Baxter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10815634021034 EUDAMED00815634021068 EUDAMEDFDA UDI10815634021041 EUDAMED
- Basic UDI-DI
- B-10815634021034 EUDAMEDB-00815634021068 EUDAMEDB-10815634021041 EUDAMED
- 510(k) Number
- K042834 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- A020199 SYRINGES, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Open-surgery adhesive/sealant applicator, dual-channel FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 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
Baxter Gasless Tip Applicator 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-10815634021034 | 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 (4)
- EUDAMED a305e451-1990-4531-a258-c474a6a5d313 61 fields · synced Jul 15, 2026
- EUDAMED 3fea5b62-4635-4b54-8590-441fbe73f2d6 61 fields · synced May 17, 2026
- EUDAMED 1f9705f1-4dd3-4025-aa4a-f373dcd3dcda 61 fields · synced May 17, 2026
- FDA UDI 71aac8c4-04de-46a7-a5ad-b42bd5c8799f 34 fields · synced May 30, 2026