FDA UDI In Commercial Distribution 🇺🇸 United States

Kaye Products - W4B

DI: 00810117140366 · Model: W4B · Kaye Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Kaye Products - W4B
Primary DI
00810117140366
Version / Model
W4B
Company Name
Kaye Products, Inc.
Labeler DUNS
082364654
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-07-05
Public Version
1
Public Version Date
2023-07-13
Public Version Status
New
Public Device Record Key
4684e201-2527-467b-8ee8-98e636b34cad

Device Description

Adolescent Posture Control Walker/Gait Trainer, 2 Wheels

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
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
Yes
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
ITJ Walker, Mechanical

GMDN Terms

Code Name
37951 Handgrip disability-assistive walker, non-powered, foldable

Identifiers

Type ID
Primary 00810117140366