FDA.reportPublic FDA data

Arm Sling

Primary DI
00616784434728
Brand
Arm Sling
Company
Dynarex Corporation
Model
4347
Device description
Cool Mesh Arm Sling- Small
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
00616784434735PackageGS110In Commercial Distribution
00616784434728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784434735006167844347356167844347350616784434735
00616784434728006167844347286167844347280616784434728

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
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01
00616784431420Senior Tongue Depressors, 6" (15.2 cm)43142021-09-01
00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
00616784435312Gait Belt, Multicolor, Metal Buckle, 60" x 2"43532021-09-01
00616784435411Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2"43542021-09-01
00616784351612Heavy Duty Fitted Cot Sheet, White, 30" x 73"35162021-09-01
00616784351711Premium Flat Cot Sheet, Dark Blue, 40" x 85"35172021-09-01
00616784368115Triangular Bandages, Non-Woven, Polybagged, 40" x 40" x 56"36812021-09-01
00616784369228Cotton Stockinette, Soft Stretch Bandage, 2" x 25 yd36922021-09-01
00616784369327Cotton Stockinette, Soft Stretch Bandage, 3" x 25 yd36932021-09-01
00616784369426Cotton Stockinette, Soft Stretch Bandage, 4" x 25 yd36942021-09-01
00616784369624Cotton Stockinette36962021-09-01
00840117349841IV Administration Sets, Non-Toxic, 20 Drops/mL, 84" (213.4 cm)70552026-06-30
00616784201221Lab Jackets Knitted Cuffs & Collar with Pockets, Small, Blue20122021-09-01
00616784201320Lab Jackets Knitted Cuffs & Collar with Pockets, Medium, Blue20132021-09-01
00616784201429Lab Coats Knitted Cuffs & Collar with Pockets, Large, Blue20142021-09-01
00616784201528Lab Jackets Knitted Cuffs & Collar with Pockets, X-Large, Blue20152021-09-01
00616784201627Lab Jackets Knitted Cuffs & Collar with Pockets, 2X-Large, Blue20162021-09-01
00616784206226Lab Coats Knitted Cuffs & Collar with Pockets, Small, White20622021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756880282DeRoyalDEROYAL INDUSTRIES, INC.ILI2026-04-02
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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