FDA UDI In Commercial Distribution 🇺🇸 United States

DALTON ROLLATOR

DI: 00815027012253 · Model: AR-4600BK · DALTON MEDICAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
DALTON ROLLATOR
Primary DI
00815027012253
Version / Model
AR-4600BK
Company Name
DALTON MEDICAL CORPORATION
Labeler DUNS
874709348
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2020-05-11
Public Version
3
Public Version Date
2022-06-10
Public Version Status
Update
Public Device Record Key
9c995a3f-bcff-4837-9ea2-1e3b74128de5

Device Description

ROLLATOR, LIGHT WEIGHT, 6" WHEEL, HAND BRAKES, BLACK, WT LIMIT 220 LBS

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
Yes
Has Serial Number
Yes
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 00815027012253