FDA.report

McKesson

Primary DI
00612479241985
Brand
McKesson
Company
MCKESSON MEDICAL-SURGICAL INC.
Model
169-10-0918
Device description
Therapy Putty x-soft resistance level 1 lb
Published
2019-05-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
IONExerciser, Non-Measuring

Product Code Classifications

CodeDeviceSpecialtyClass
IONExerciser, Non-MeasuringPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00612479241985PackageGS124In Commercial Distribution
00612479241978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00612479241985006124792419856124792419850612479241985
00612479241978006124792419786124792419780612479241978

GMDN Terms

TermDefinition
Finger/hand exerciserA non-powered device intended primarily to strengthen the muscles of the fingers and hands through repetitive finger/hand motion against resistance from elasticity or density. It is available in a variety of forms including handgrips (some types with individual buttons to work each finger independently), elastic balls and webs, putty, and hand-held devices with elastic bands. The device may also help improve finger/hand flexibility and coordination, and help improve wrist and forearm strength.

Sterilization Methods

Method

Regulatory Flags

DUNS number
023904428
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00612479282179McKesson16-4839-22026-03-17
00612479124448McKesson16-71312026-03-11
00612479124455McKesson16-71322026-03-11
00612479124462McKesson16-71332026-03-11
00612479135468McKesson16-71352026-03-11
00612479135512McKesson16-71362026-03-11
00612479160651McKesson70-101PMCK2026-03-11
00612479160668McKesson70-105PMCK2026-03-11
00612479160675McKesson70-109PMCK2026-03-11
00612479185388McKesson70-1121MCK2026-03-11
00612479185395McKesson70-1122MCK2026-03-11
40612479280920McKesson16-1000-PMBL2026-02-26
40612479262162McKesson18-3300M2026-02-23
10612479275932McKesson91-31052026-02-20
10612479281575McKesson181-342252026-02-06
10612479281582McKesson181-342252026-02-06
00612479278356McKesson16-61442026-01-26
00612479278370McKesson16-61482026-01-26
00612479278387McKesson16-61682026-01-26
00612479278431McKesson16-618102026-01-26

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