FDA.reportPublic FDA data

Arm Sling

Primary DI
00616784434827
Brand
Arm Sling
Company
Dynarex Corporation
Model
4348
Device description
Cool Mesh Arm Sling- Medium
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILISling, Arm

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILISling, ArmPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784434834PackageGS110In Commercial Distribution
00616784434827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784434834006167844348346167844348340616784434834
00616784434827006167844348276167844348270616784434827

GMDN Terms#

Term, Definition table
TermDefinition
Arm immobilization sling, reusableA non-powered, non-rigid wearable device intended to support, align, and temporarily immobilize the arm (including the shoulder) to support the healing of an injury or surgical wound. It typically consists of a fabric or foam sling secured over the shoulder(s) with an adjustable strap and/or a strap around the abdomen and upper arm to secure the arm in place. It may be suspended from an overhead support to elevate the extremity to aid in controlling oedema, enhancing recovery typically following hand or forearm surgery. It is neither an elbow orthosis nor triangular bandage and does not include a hinge mechanism. This is a reusable device.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117346307Vital Signs Stand, Compatible with item 10843108562026-06-08
00840117349544Drape Sheets, Tissue / Poly 2-ply, Black, 40" x 90" (101.6 cm x 228.6 cm)8150BLK2026-06-08
00840117349568Pillow Cases, Tissue / Poly 2-ply, Black, 21" x 30" (53.3 cm x 76.2 cm)8161BLK2026-06-08
00840117327610Titan-700 Bariatric Rollator102172023-12-28
00840117325968Platform Attachment102122023-03-24
00840117326026Dynarex Bari + Max Bariatric Platform Attachment102132023-03-24
00616784020419Vivid-Flex, Adjustable Height Rollator102042019-10-07
00616784021515Compact Steerable Knee Walker, With Basket, Steel102152019-10-08
00616784021614Steerable Knee Walker with Basket102162019-10-08
00616784020815DynaGo Duo Transport Rollator With 7.5" Casters and Plastic Footrest102082019-11-13
00840117325913Bari + Max Bariatric HD Steel Walker, Weight Capacity 700 lb.101692023-01-09
00840117336483Steel Button Folding Walker with 5 Wheels, Adults101702024-06-17
00616784020013DynaGo Zoom - Aluminum Rollator with 3" Wheels102002019-10-07
00616784020112Vivid-Quad, Rollator, With 6" Caster , Blue10201BL2019-10-07
00616784020211Vivid-Terrain, Rollator with 7.5" Caster102022019-10-07
00616784020310Titan-500 Bariatric Rollator102032019-10-07
00616784020129Vivid-Quad, Rollator, With 6" Caster, Red10201RD2019-11-07
00616784020136Vivid-Quad, Rollator, With 6" Caster, Black10201BK2019-11-07
00616784020143Vivid-Quad, Rollator, With 6" Caster, Pink10201PK2019-11-07
00616784016016DMECare Solutions Two Button Folding Walker, Adult (32"-39")101602019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756880282DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880299DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880312DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880329DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880336DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880343DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880930DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880947DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880954DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
00749756880961DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
06974500613616Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
06974500613623Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613613Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613620Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
00810113683041Kangaroo 3960Manamed, Inc.ILI2025-10-17
00810113683027Shoulder Brace with Airplane KitManamed, Inc.ILI2025-09-19
00810113683034Shoulder Brace with Airplane Kit LOGOManamed, Inc.ILI2025-09-19
00190446660354PROCAREDJO, LLCILI2025-07-14
00749756397841DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
50749756397846DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
00749756397285DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-13
00840314811097UNIV ARM SLING W/FOAM STRAP ADULTHausmann Enterprises, LLCILI2025-01-01
M68932600100CravatSafeguard US Operating, LLCILI2024-10-09
00810113576947CoreTechVIVE HEALTH LLCILI2024-06-10
10810113576944CoreTechVIVE HEALTH LLCILI2024-06-10
00057475611026BIOS LivingThermor LtdILI2024-05-23
10057475611023BIOS LivingThermor LtdILI2024-05-23
00888912014366DONJOYDJO, LLCILI2024-02-27
07798094540061WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540078WELLBRACEPANTYMED S.A.ILI2024-01-05