Guided DAS Surgical Kit
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- DYNAMIC ABUTMENT SOLUTIONS FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- KIT EUDAMEDGuided DAS Surgical Kit FDA UDI
- Model / Reference
- 79.900.005.01-2 EUDAMEDFDA UDIACCKIT05 EUDAMED
- Description
- Guided DAS Surgical Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435673509994 EUDAMEDFDA UDI
- Basic UDI-DI
- 843656873ACCKIT053E EUDAMED
- 510(k) Number
- FDA Product Code
- KCT FDA 510(k)FDA UDI
- EMDN Code
- S9099 STERILISATION DEVICES (EXCLUDING CAT. D - Z) - OTHER EUDAMED
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 880.6850 FDA 510(k)
- Regulation Number
- 880.6850 FDA 510(k)FDA UDI
- Market of Registration
- Spain EUDAMED
- Advisory Committee
- General Hospital FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The Guided DAS Surgical Kit is a sterilization wrap (product code KCT) designed to enclose medical devices for sterilization purposes. It serves as a protective barrier to ensure sterility during the sterilization process, maintaining the integrity of enclosed instruments or supplies.
This kit is intended for use in general hospital settings and is supplied as a single-use item. It is regulated under FDA 510(k) clearance and MDR, adhering to 21 CFR 880.6850 for sterilization wraps. The device is not reusable and must be stored in a clean, dry environment prior to use.
Frequently asked questions
What is the Guided DAS Surgical Kit used for in a clinical setting?
The Guided DAS Surgical Kit is designed as a sterilization wrap to protect medical devices or supplies during sterilization. It acts as a barrier to preserve sterility and the integrity of enclosed items, ensuring they remain uncontaminated for surgical use. It’s intended for general hospital settings where maintaining sterile conditions is critical.
Is the Guided DAS Surgical Kit reusable, or is it meant for single-use only?
The kit is explicitly labeled as a single-use item and must not be reused. This designation ensures patient safety by preventing cross-contamination and maintaining sterility standards for each surgical procedure.
How should the Guided DAS Surgical Kit be stored before use?
Prior to use, the kit must be stored in a clean, dry environment to prevent moisture or contamination. Proper storage conditions are essential to preserve its integrity and ensure it remains suitable for sterilization and surgical use.
What regulatory pathways does the Guided DAS Surgical Kit follow?
The kit is cleared under FDA 510(k) (K243425) and complies with the MDR (Medical Device Regulation). It falls under 21 CFR 880.6850, which governs sterilization wraps, and was determined to be substantially equivalent to predicate devices through a traditional review process.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Guided DAS Surgical Kit by Talladium España, SL | FDA 510(k) Summary, PDF Talladium España, SL ℅ Rebecca Kattan Regulatory Specialist 12264 El ..., Guided DAS Surgical Kit (K243425) — FDA 510(k) | Innolitics
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243425 | Class II | Active |
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Manufacturer
- Manufacturer
- Talladium España Sl
- FDA Applicant
- Talladium España, SL
Sources (3)
- FDA 510(k) K243425 24 fields · synced Sep 18, 2026
- FDA UDI a171cdfd-a43a-4440-8352-f955348de48a 36 fields · synced May 30, 2026
- EUDAMED ce509c88-e0a1-4ecc-886f-0b27f191406f 61 fields · synced Jul 8, 2026