Identity
- Trade Name
- Simply Surgical Kit Conical FDA UDI
- Generic Name
- Device sterilization/disinfection container, reusable FDA UDI
- Device Name
- Drills & Tools (Qty 19) Tray (Qty 1) FDA UDI
- Model / Reference
- SSK-C FDA UDI
- Description
- Drills & Tools (Qty 19) Tray (Qty 1) FDA UDI
Identifiers
- Catalog Number
- SSK-C FDA UDI
- Primary DI / UDI-DI
- 10841307135876 FDA UDI
- 510(k) Number
- K202524 FDA UDI
- FDA Product Code
- KCT FDA UDI
- GMDN Term
- Device sterilization/disinfection container, reusable 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
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
Yes
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Device sterilization/disinfection container, reusable
Simply Surgical Kit Conical by Implant Direct Sybron Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Device sterilization/disinfection container, reusable.
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Cleared under the same submission
K202524 also covers:
- InterActive® Surgical Kit — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- InterActive® Surgical Kit Empty — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Simply Surgical Kit Legacy — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Standard Surgical Kit — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Standard Surgical Kit - Simply Iconic™ — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Standard Surgical Kit -Legacy™ — IMPLANT DIRECT SYBRON MANUFACTURING LLC
- Standard Surgical Kit Empty — IMPLANT DIRECT SYBRON MANUFACTURING LLC
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
- Implant Direct Sybron Manufacturing Llc
Sources (1)
- FDA UDI b6475297-40fe-4649-936a-665107c233b5 36 fields · synced May 30, 2026