← Back to catalogue

Vectr

FDA UDI

Class II (US FDA UDI)

by Rafael Medical Devices, Llc

Identity

Trade Name
VECTR FDA UDI
Generic Name
Hand ligament surgical release instrument FDA UDI
Device Name
VECTR - Video Endoscopic Carpal Tunnel Release System FDA UDI
Model / Reference
5200-01 FDA UDI
Description
VECTR - Video Endoscopic Carpal Tunnel Release System FDA UDI

Identifiers

Primary DI / UDI-DI
00860010523902 FDA UDI
510(k) Number
K242417 FDA UDI
FDA Product Code
HRX FDA UDI
EMF FDA UDI
GMDN Term
Hand ligament surgical release instrument FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
878.4800 FDA UDI
Commercial Distribution
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
MRI Safety
MR Unsafe FDA UDI

Category: Hand ligament surgical release instrument

Vectr by Rafael Medical Devices, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand ligament surgical release instrument.

Cleared under the same submission

K242417 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Rafael Medical Devices, Llc

Sources (1)

  • FDA UDI 07ddd342-d261-4281-aa9e-ea9648b54a59 35 fields · synced May 30, 2026