Identity
- Trade Name
- XIOS XG FDA UDI
- Generic Name
- Instrument/equipment drape, single-use, non-sterile FDA UDI
- Device Name
- XIOS XG SELECT SIZE 2 SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG) FDA UDI
- Model / Reference
- 6409952 FDA UDI
- Description
- XIOS XG SELECT SIZE 2 SHEATHS UNIVERSAL SHEATHS SIZE 1 (300/PKG) FDA UDI
Identifiers
- Primary DI / UDI-DI
- D76464099521 FDA UDI
- 510(k) Number
- K132953 FDA UDI
- FDA Product Code
- PEM FDA UDI
- GMDN Term
- Instrument/equipment drape, single-use, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument/equipment drape, single-use, non-sterile
Xios Xg by Sirona Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K132953 also covers:
- SCHICK — SIRONA DENTAL, INC.
- SCHICK — SIRONA DENTAL, INC.
- XIOS — SIRONA DENTAL, INC.
- XIOS — SIRONA DENTAL, INC.
- XIOS XG — SIRONA DENTAL, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO — ULTRADENT PRODUCTS, INC.
- VALO GRAND — ULTRADENT PRODUCTS, INC.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, Inc.
- Defend — Young Innovations, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sirona Dental, Inc.
Sources (1)
- FDA UDI 2d3defe2-0b75-4726-b4e0-ee7d1c531e38 35 fields · synced May 30, 2026