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Introducer/Stiffener for Initial Placement
EUDAMEDFDA UDIClass I (EU MDR)
Ref E4-6000
Identity
- Trade Name
- Introducer/Stiffener for Initial Placement EUDAMEDAMT Stiffener for Initial Placement FDA UDI
- Generic Name
- Peritoneal catheter stylet FDA UDI
- Device Name
- Introducer/Stiffener EUDAMEDGuidewire Compatible Stiffener for Initial Placement (Pouched), MDR FDA UDI
- Model / Reference
- E4-6000 EUDAMEDFDA UDI
- Description
- Guidewire Compatible Stiffener for Initial Placement (Pouched), MDR FDA UDI
Identifiers
- Catalog Number
- E4-6000, 4-6000 FDA UDI
- Primary DI / UDI-DI
- 00842071136369 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711INTRODUCER49 EUDAMED
- 510(k) Number
- K042300 FDA UDI
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G020299 GASTROINTESTINAL FEEDING/ASPIRATION TUBES - OTHER EUDAMED
- GMDN Term
- Peritoneal catheter stylet FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Market of Registration
- Ireland 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Introducer/Stiffener for Initial Placement by Applied Medical Technology, Inc. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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 | 08420711INTRODUCER49 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Applied Medical Technology, Inc.
- EUDAMED SRN
- US-MF-000041414
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 8bc23a83-5e87-4dfe-92d9-15a34f8be88e 61 fields · synced Jun 18, 2026
- FDA UDI 3249f36f-fe1a-417a-8cbe-99960865fc75 36 fields · synced May 29, 2026