DALTON ROLLATOR

GUDID 00815027012253

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

DALTON MEDICAL CORPORATION

Basic walker, foldable
Primary Device ID00815027012253
NIH Device Record Key9c995a3f-bcff-4837-9ea2-1e3b74128de5
Commercial Distribution StatusIn Commercial Distribution
Brand NameDALTON ROLLATOR
Version Model NumberAR-4600BK
Company DUNS874709348
Company NameDALTON MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815027012253 [Primary]

FDA Product Code

ITJWalker, Mechanical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-05-19
Device Publish Date2020-05-11

On-Brand Devices [DALTON ROLLATOR]

00815027012253ROLLATOR, LIGHT WEIGHT, 6" WHEEL, HAND BRAKES, BLACK, WT LIMIT 220 LBS
00815027012246ROLLATOR, LIGHT WEIGHT, 6" WHEELS, HAND BRAKE, RED, WT LIMIT 220 LBS

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