FDA.reportPublic FDA data

"Rotating Flange With Textured Grip Knurled Grab Bar 12"""

Primary DI
00616784031118
Brand
"Rotating Flange With Textured Grip Knurled Grab Bar 12"""
Company
Dynarex Corporation
Model
10311
Published
2019-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILSAdaptor, Hygiene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILSAdaptor, HygienePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784031118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784031118006167840311186167840311180616784031118

GMDN Terms#

Term, Definition table
TermDefinition
Parallel bar exerciser, non-poweredAn exercise apparatus designed to assist users in maintaining good walking posture, particularly a person with a disability, a paraplegic, or a patient who has suffered a stroke and is learning to walk. It typically consists of two parallel wooden or steel handrails each one supported by two poles and base plates; the user holds the bars, which may be manually height and width-adjustable, thus relieving his/her weight when walking. The device is intended to improve the user?s balance as well as coordination and flexibility; additionally, it can improve the muscle strength in the lower limbs.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117320925Resp-O2 Incentive Spirometer. Tri-Flow Chamber361022021-04-22
00840117324510Dynarex Bari + Max Bariatric HD Composit Swing Down Rail129542022-11-01
00616784295015Metal Swing Rail129502022-05-09
00616784295114Composite Swing Rail129512022-05-09
00616784295213Q Assist Bar129522022-05-09
00616784295312Pivot Assist Bar129532022-05-09
00616784296012Universal Rotating Assist Bar129602022-05-09
00616784296111Universal Pivot Assist Bar129612022-05-09
00840117303478Expansion Kit for D300129142022-05-09
00840117348578Standard Sling Seat/Back Sling, Mesh10750MS2019-12-30
00840117348592Standard Sling Seat/Back Sling, Canvas10750CN2019-12-30
00840117348615Standard Sling Seat/Back Sling, Mesh With Commode Opening10751MS2019-12-30
00840117348639Standard Sling Seat/Back Sling, Canvas With Commode Opening10751CN2019-12-30
00840117348653Standard Seat/Back Sling - Canvas, Adult Large107522019-12-30
00616784075419Replacement Straps For Standard Slings107542021-04-19
00840117324527Bariatric HD Long-Term Care Bed, DB600, 5 Function Low Bed, Expands to 54"120142022-11-21
00840117302891Long-Term Care Bed, D100120012021-02-03
00840117302907Long Term Care Bed, D200120022021-02-03
00840117302914Long-Term Care Bed D300, 5 Function Low Bed120032021-02-03
00840117302945Bariatric HD Long-Term Care Bed, DB300, 5 Function Low Bed120132021-02-03

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04895262521020HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
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04895262521051HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-14
04895262521044HOMLANDHongKong Pishon Medical Equipment Co., LimitedILS2026-04-13
00023601023827CarexDrive Devilbiss HealthcareILS2026-04-07
00023601658500CarexDrive Devilbiss HealthcareILS2026-01-12
00023601088215CarexDrive Devilbiss HealthcareILS2025-10-16
00023601088208CarexDrive Devilbiss HealthcareILS2025-06-25
00810178882403ViveVIVE HEALTH LLCILS2025-05-20