Identity
- Trade Name
- Sklar® FDA UDI
- Generic Name
- Sterilization container filter, single-use FDA UDI
- Device Name
- SAMPLE SKLARLITE FILTERS PK/20 FDA UDI
- Model / Reference
- 10-4910S FDA UDI
- Description
- SAMPLE SKLARLITE FILTERS PK/20 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 30649111113219 FDA UDI
- 510(k) Number
- K931202 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Sterilization container filter, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization container filter, single-use
Sklar® by Sklar Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K931202 also covers:
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- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Henry Schein — HENRY SCHEIN, INC.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
- Arjo Wiggins Medical, Inc. — Sterimed, Inc.
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
- Sklar Corporation
Sources (1)
- FDA UDI 06b208a8-4d5b-4072-87a8-78eaf33f019b 34 fields · synced Jun 1, 2026