Identity
- Trade Name
- Removal Tool EUDAMEDNon-Balloon Removal Tool FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- Non-Balloon Removal Tool EUDAMED18-24F x 3.4-3.7cm Non-Balloon Removal Tool (MDR) FDA UDI
- Model / Reference
- R-L3437 EUDAMEDFDA UDI
- Description
- 18-24F x 3.4-3.7cm Non-Balloon Removal Tool (MDR) FDA UDI
Identifiers
- Catalog Number
- R-L3437 FDA UDI
- Primary DI / UDI-DI
- 00842071132149 EUDAMEDFDA UDI
- Basic UDI-DI
- 08420711REMOVALTOOLTZ EUDAMED
- FDA Product Code
- KNT FDA UDI
- EMDN Code
- G020299 GASTROINTESTINAL FEEDING/ASPIRATION TUBES - OTHER EUDAMED
- GMDN Term
- Gastrostomy button 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
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
Removal Tool by Applied Medical Technology, Inc. — Class I — 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 | 08420711REMOVALTOOLTZ | 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 208e402b-8b2f-4710-811c-d4a91546d562 61 fields · synced Jun 9, 2026
- FDA UDI 3908bfe6-4be1-45ae-b9e1-1b897d063d1f 37 fields · synced May 24, 2026