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Tearaway Introducer Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref INT-106-33Model INT-XXX-XX
Identity
- Trade Name
- Tearaway Introducer Set EUDAMEDFDA UDI
- Generic Name
- Vascular catheter introduction set, nonimplantable FDA UDI
- Device Name
- Tearaway Product Family EUDAMEDTearaway Introducer Set FDA UDI
- Model / Reference
- INT-XXX-XX EUDAMEDINT-106-33 EUDAMEDFDA UDI
- Description
- Tearaway Introducer Set FDA UDI
Identifiers
- Catalog Number
- INT-106-33 FDA UDI
- Primary DI / UDI-DI
- 00841268102286 EUDAMEDFDA UDI
- Basic UDI-DI
- 08412681Tearaway-INTEC EUDAMED
- FDA Product Code
- DYB FDA UDI
- EMDN Code
- C0503 CARDIOVASCULAR INTRODUCER SHEATHS, PEEL-AWAY EUDAMED
- GMDN Term
- Vascular catheter introduction set, nonimplantable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1340 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Ethylene Oxide FDA UDI
Dimensions & Sizes
- Size
- Catheter Gauge — 5 French FDA UDI
Tearaway Introducer Set by Galt Medical Corp. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08412681Tearaway-INTEC | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Galt Medical Corp.
- EUDAMED SRN
- US-MF-000001777
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 04bc5733-76e2-4790-a708-f85cbf8b9163 61 fields · synced Oct 6, 2026
- FDA UDI e38688b2-401d-408a-abe5-51e326e48866 36 fields · synced May 30, 2026