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 Open, OUS - Baxter FDA UDI
- Model / Reference
- 601156 EUDAMEDFDA UDI
- Description
- Gasless Applicator Open, OUS - Baxter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815634021037 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00815634021037 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-00815634021037 | 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 3f9ad404-b9e2-498a-85fa-c41ed5472ad5 61 fields · synced Jun 19, 2026
- FDA UDI 1ab54583-8aac-4fa1-9cc9-7a9efca42f88 34 fields · synced May 30, 2026