Identity
- Trade Name
- Sky-Lube FDA UDI
- Generic Name
- Surgical instrument maintenance lubricant FDA UDI
- Device Name
- Instrument Lubricant, 5 gallon container with 61mm cap FDA UDI
- Model / Reference
- J5-010-14 FDA UDI
- Description
- Instrument Lubricant, 5 gallon container with 61mm cap FDA UDI
Identifiers
- Catalog Number
- J5-010-14 FDA UDI
- Primary DI / UDI-DI
- 10841736100711 FDA UDI
- FDA Product Code
- MEC FDA UDI
- GMDN Term
- Surgical instrument maintenance lubricant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6992 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument maintenance lubricant
Sky-Lube by Skytron, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 d05c52b5-6910-4049-bdbf-c52b24960089 35 fields · synced Jun 8, 2026