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AMT PEG-Assist® Initial Placement GI Kit
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref IP-10-S
Identity
- Trade Name
- AMT PEG-Assist® Initial Placement GI Kit EUDAMEDAMT Initial Placement Kit FDA UDI
- Generic Name
- Gastrostomy procedure kit FDA UDI
- Device Name
- AMT Initial Placement Kit with Sheathed Dilator EUDAMEDAMT Initial Placement Kit with Sheath (10F), MDR FDA UDI
- Model / Reference
- IP-10-S EUDAMEDFDA UDI
- Description
- AMT Initial Placement Kit with Sheath (10F), MDR FDA UDI
Identifiers
- Catalog Number
- IP-10-S FDA UDI
- Primary DI / UDI-DI
- 00842071140144 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711SHEATHEDIPKIT9U 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
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
AMT PEG-Assist® Initial Placement GI Kit by Applied Medical Technology, Inc. — Class IIa — 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 | 08420711SHEATHEDIPKIT9U | 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 fe62ca81-7baf-458a-9541-b19dee57f907 61 fields · synced Jun 19, 2026
- FDA UDI a57f1f82-16ea-4807-9d13-fd8ac5cc6256 37 fields · synced May 30, 2026