Identity
- Trade Name
- ZUTRON FDA UDI
- Generic Name
- Invasive medical device leak tester, electrical FDA UDI
- Device Name
- LEAK TESTER - COUNTER FDA UDI
- Model / Reference
- ZUTR10003P FDA UDI
- Description
- LEAK TESTER - COUNTER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04961333244485 FDA UDI
- 510(k) Number
- K093718 FDA UDI
- FDA Product Code
- FCY FDA UDI
- GMDN Term
- Invasive medical device leak tester, electrical FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Invasive medical device leak tester, electrical
Zutron by PENTAX of America, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Invasive medical device leak tester, electrical.
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- MAINTENANCE UNIT — Olympus Medical Systems Corporation · Class II
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- MAINTENANCE UNIT — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- PENTAX of America, Inc.
Sources (1)
- FDA UDI 3bea3fe1-cd2c-4f67-97bf-85be7af31031 34 fields · synced May 29, 2026