Identity
- Trade Name
- Attachment Pillows FDA UDI
- Generic Name
- Radiological general body-part positioner FDA UDI
- Device Name
- Attachment Pillows FDA UDI
- Model / Reference
- B FDA UDI
- Description
- Attachment Pillows FDA UDI
Identifiers
- Catalog Number
- XR-ATT-PLW FDA UDI
- Primary DI / UDI-DI
- 07290017702179 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 Pillows by Xact Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 Towel — 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 |
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Manufacturer
- Manufacturer
- Xact Robotics Ltd
Sources (1)
- FDA UDI eec7b56a-4e21-434c-8342-bc474c78b414 36 fields · synced Jun 6, 2026