Identity
- Trade Name
- F88 FDA UDI
- Generic Name
- Invasive medical device leak tester, mechanical FDA UDI
- Device Name
- Manual Leak Tester FDA UDI
- Model / Reference
- 0503388008 FDA UDI
- Description
- Manual Leak Tester FDA UDI
Identifiers
- Catalog Number
- 0503388008 FDA UDI
- Primary DI / UDI-DI
- 08881300750077 FDA UDI
- 510(k) Number
- K243894 FDA UDI
- FDA Product Code
- FGB FDA UDI
- GMDN Term
- Invasive medical device leak tester, mechanical FDA UDI
Classification
- Device Class
- Class II 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
Yes
FDA UDI
Category: Invasive medical device leak tester, mechanical
F88 by Sg Endoscopy Pte, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Invasive medical device leak tester, mechanical.
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- FUJIFILM — FUJIFILM Corporation · Class I
- ZUTRON — PENTAX of America, Inc. · Class I
- Sonata® IUUS Probe Leak Tester — Gynesonics, Inc. · Class I
- Sonata® IUUS probe Leak Tester Kit — Gynesonics, Inc. · Class I
Cleared under the same submission
K243894 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Sg Endoscopy Pte, Ltd.
Sources (1)
- FDA UDI 9f607d5b-d1be-4ca7-b90f-58cdaac91f0f 36 fields · synced Jun 8, 2026