Identity
- Trade Name
- Attachment Towel FDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- Attachment Towel FDA UDI
- Model / Reference
- B FDA UDI
- Description
- Attachment Towel FDA UDI
Identifiers
- Catalog Number
- XR-ATT-TWL FDA UDI
- Primary DI / UDI-DI
- 07290017702230 FDA UDI
- 510(k) Number
- K191332 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Radiological general body-part positioner FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1750 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
Yes
FDA UDI
Category: Radiological general body-part positioner
Attachment Towel by Xact Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological general body-part positioner.
- Oakworks Medical — OAKWORKS, INC. · Class II
- AADCO — AADCO MEDICAL, INC. · Class I
- Techno-Aide — TECHNO-AIDE, INC. · Class I
- Techno-Aide — TECHNO-AIDE, INC. · Class I
- Techno-Aide — TECHNO-AIDE, INC. · Class I
- pearltec — Pearl Technology AG · Class I
- AADCO — AADCO MEDICAL, INC. · Class I
- Oakworks Medical — OAKWORKS, INC. · Class II
Cleared under the same submission
K191332 also covers:
- 1.7 mm Ablation Instrument Insertion Kit — XACT ROBOTICS LTD
- 2.1 mm Ablation Instrument Insertion Kit — XACT ROBOTICS LTD
- Aiming Plate Drape — XACT ROBOTICS LTD
- Attachment Frame — XACT ROBOTICS LTD
- Attachment Pillows — XACT ROBOTICS LTD
- Frame-Harness Strap Set — XACT ROBOTICS LTD
- Respiration Sensor Drape — XACT ROBOTICS LTD
- XACT Robotics: 17g Needle Threading Jig — XACT ROBOTICS LTD
- XACT Robotics: 18g Needle Threading Jig — XACT ROBOTICS LTD
- XACT Robotics: 19g Needle Threading Jig — XACT ROBOTICS LTD
- XACT Robotics: Disposable Kit — XACT ROBOTICS LTD
- XACT Robotics: Harness (L) — XACT ROBOTICS LTD
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
- Xact Robotics Ltd
Sources (1)
- FDA UDI fb8e9014-953d-409a-87cb-1bfd08876d13 36 fields · synced May 30, 2026