Identity
- Trade Name
- XACT Robotics: Disposable Kit FDA UDI
- Generic Name
- Medical equipment/instrument drape, single-use FDA UDI
- Device Name
- XACT Robotics: Disposable Kit FDA UDI
- Model / Reference
- A FDA UDI
- Description
- XACT Robotics: Disposable Kit FDA UDI
Identifiers
- Catalog Number
- XR-DIS-KIT FDA UDI
- Primary DI / UDI-DI
- 07290017702155 FDA UDI
- 510(k) Number
- K191332 FDA UDI
- FDA Product Code
- JAK FDA UDI
- GMDN Term
- Medical equipment/instrument drape, single-use 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
Yes
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
Category: Medical equipment/instrument drape, single-useRadiological general body-part positionerMedical/surgical interventional tube/cable securement strapRobotic surgical needle holder, single-use
XACT Robotics: Disposable Kit by Xact Robotics Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical needle holder, single-use.
- XACT Robotics: 17g Needle Threading Jig — XACT ROBOTICS LTD · Class II
- 1.7 mm Ablation Instrument Insertion Kit — XACT ROBOTICS LTD · Class II
- XACT Robotics: 18g Needle Threading Jig — XACT ROBOTICS LTD · Class II
- XACT Robotics: 19g Needle Threading Jig — XACT ROBOTICS LTD · Class II
- 1.5mm Ablation Instrument Insertion Kit — XACT ROBOTICS LTD · Class II
- 2.1 mm Ablation Instrument Insertion Kit — XACT ROBOTICS LTD · 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
- 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: 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 fe17c099-79b7-4827-9305-a26fc617bbe3 36 fields · synced Jun 6, 2026