AMT Initial Placement Dilator Set
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- AMT Initial Placement Dilator Set EUDAMEDFDA UDI
- Generic Name
- Gastrostomy procedure kit FDA UDI
- Device Name
- AMT Initial Placement Dilator Set EUDAMEDAMT Initial Placement Dilator Kit (10F), MDR FDA UDI
- Model / Reference
- IP-DIL-10 EUDAMEDFDA UDI
- Description
- AMT Initial Placement Dilator Kit (10F), MDR FDA UDI
Identifiers
- Catalog Number
- IP-DIL-10 FDA UDI
- Primary DI / UDI-DI
- 00842071140182 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711DILATORSETN2 EUDAMED
- 510(k) Number
- K073034 FDA UDI
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- V9012 NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE EUDAMED
- GMDN Term
- Gastrostomy procedure kit FDA UDI
Classification
- Device Class
- Class IIa 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
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
Yes
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Surgical retractor/retraction system blade, single-use
AMT Initial Placement Dilator Set by Applied Medical Technology, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical retractor/retraction system blade, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08420711DILATORSETN2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | 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 c3ef0895-e0d1-4b89-9333-c4b6fc6ab3f2 61 fields · synced Jun 9, 2026
- FDA UDI 7ec1c373-e234-4f59-a50c-d3abcec868be 37 fields · synced May 30, 2026