FDA UDI In Commercial Distribution 🇺🇸 United States

CAT EX

DI: G041CT0060 · Model: CT006 · JTECH Medical
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
CAT EX
Primary DI
G041CT0060
Version / Model
CT006
Company Name
JTECH Medical
Labeler DUNS
625089131
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2021-05-14
Public Version
2
Public Version Date
2023-07-13
Public Version Status
Update
Public Device Record Key
cd32685e-51cf-4d71-a694-55f1e3309495

Device Description

A hand-held, non-powered mechanical device intended to be used by a healthcare professional for the adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. This is a reusable, non-invasive, non-surgical, non-sterile, transient.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
LXM Manipulator, Plunger-Like Joint

GMDN Terms

Code Name
63426 Joint/spinal manipulator, mechanical

Identifiers

Type ID
Primary G041CT0060

Customer Contacts

Phone
385-695-5000

Premarket Submissions

Submission Number Supplement Number
K974376 000