Identity
- Trade Name
- Jewel Precision FDA UDI
- Generic Name
- Instrument transport trolley system FDA UDI
- Device Name
- Filter, Single Use Only FDA UDI
- Model / Reference
- 100-0003 FDA UDI
- Description
- Filter, Single Use Only FDA UDI
Identifiers
- Catalog Number
- 100-0003 FDA UDI
- Primary DI / UDI-DI
- 00850043393108 FDA UDI
- 510(k) Number
- K162600 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Instrument transport trolley system 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Instrument transport trolley system
Jewel Precision by Jewel Precision Sheet Metal & Machining, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K162600 also covers:
- gSource — GSOURCE, LLC.
- gSource — GSOURCE, LLC.
- Jewel Precision — JEWEL PRECISION SHEET METAL & MACHINING, INC.
- Jewel Precision — JEWEL PRECISION SHEET METAL & MACHINING, INC.
- Jewel Precision — JEWEL PRECISION SHEET METAL & MACHINING, INC.
- Jewel Precision — JEWEL PRECISION SHEET METAL & MACHINING, INC.
- Jewel Precision — JEWEL PRECISION SHEET METAL & MACHINING, 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
- Jewel Precision Sheet Metal & Machining, Inc.
Sources (1)
- FDA UDI eae12d18-4a67-4a72-b764-c81d8535865d 35 fields · synced May 30, 2026