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Drape, sterile for motor or footswitch (Straub Medical®)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Drape, sterile for motor or footswitch (Straub Medical®) FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- The plastic sleeve is used to cover and keep the handle/motor or footswitch clean and allows the motor to enter the sterile field. FDA UDI
- Model / Reference
- Version 1.0 FDA UDI
- Description
- The plastic sleeve is used to cover and keep the handle/motor or footswitch clean and allows the motor to enter the sterile field. FDA UDI
Identifiers
- Catalog Number
- 80068 FDA UDI
- Primary DI / UDI-DI
- 07640142810193 FDA UDI
- 510(k) Number
- K172315 FDA UDI
- FDA Product Code
- KKX FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4370 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 18.5 Centimeter FDA UDILength — 340 Centimeter FDA UDI
Drape, sterile for motor or footswitch (Straub Medical®) by Straub Medical AG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K172315 also covers:
- Drive System (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/220cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/270cm angled (Straub Medical®) — Straub Medical AG
- Guidewire 0.018 4/320cm angled (Straub Medical®) — Straub Medical AG
- SET Rotarex™S 6 F x 110 cm — Straub Medical AG
- SET Rotarex™S 6 F x 135 cm — Straub Medical AG
- SET Rotarex™S 8 F x 110 cm — Straub Medical AG
- SET Rotarex™S 8 F x 85 cm — Straub Medical AG
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
- Straub Medical AG
Sources (1)
- FDA UDI ef22f639-44de-4fad-a4c3-3309108dcbfd 38 fields · synced May 31, 2026