Identity
- Trade Name
- Integrity Sterilizers FDA UDI
- Generic Name
- Steam sterilizer FDA UDI
- Device Name
- Integrity 215SG Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, Steam Generator FDA UDI
- Model / Reference
- INTEGRITY 215SG FDA UDI
- Description
- Integrity 215SG Vacuum/Gravity Steam Sterilizer, 21.5"W x 21.5"H x 38"D, Vertical Power Sliding Door w/ Foot Pedal Control, Water Ejector Vacuum System, Steam Generator FDA UDI
Identifiers
- Catalog Number
- INTEGRITY 215SG FDA UDI
- Primary DI / UDI-DI
- 10841736100087 FDA UDI
- 510(k) Number
- K120149 FDA UDI
- FDA Product Code
- FLE FDA UDI
- GMDN Term
- Steam sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6880 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Steam sterilizer
Integrity Sterilizers by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K120149 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
- Skytron, LLC
Sources (1)
- FDA UDI f7272dee-7ac9-4737-b9d8-3d77db5df342 37 fields · synced Jun 6, 2026