FDA.reportPublic FDA data

Cravat

Primary DI
M68932600040
Brand
Cravat
Company
Safeguard US Operating, LLC
Model
04
Catalog number
32-600
Device description
"CRAVAT1 ea - 37""x52"" triangle bandage, 2 ea - safety pins"
Published
2018-07-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
M68932600040PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suspension arm slingA non-sterile hanging triangular-shaped loop, suspended from a patient's neck/shoulder, typically intended to support an injured arm and limit its range of motion, or immobilize it, during the period of healing. It is typically fashioned from a single sheet of textile material by tying/fastening the ends. This is a reusable device intended for single-patient use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118492643
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M6898723101030Bleeding Control Kit0387-231-012026-07-30
M689HHTWBC020TACWrap Multi-Purpose Burn Cravat02HHTWBC2026-07-28
M689HHTWBC25010TACWrap Multi-Purpose Burn Cravat Case of 2501HHTWBC-252026-07-28
M6898810501060Patrol Officer IFAK Basic0688-105-012026-07-27
M6898810502060Patrol Officer IFAK Intermediate0688-105-022026-07-27
M6898810503070Patrol Officer IFAK Advanced0788-105-032026-07-27
M6898723101020Bleeding Control Kit0287-231-012026-07-22
M68920510060Sentinel Chest Trauma Kit0620-5102022-11-28
M68920510050Sentinel Chest Trauma Kit0520-5102022-08-18
M68920510030Sentinel Chest Trauma Kit0320-5102018-09-13
M6898332401060Mojo Combat Lifesaver Bag - Basic0683-324-012019-08-06
M68985205020Mojo Vehicle Rescue Bag - Advanced0285-2052026-07-22
M68985301040Mojo Vehicle Medical Bag - Basic0485-3012026-07-22
M68985303040Mojo Vehicle Medical Bag - Intermediate0485-3032026-07-22
M6898710003060Individual Trauma Kit - Advanced0687-100-032026-07-22
M6898730002040Medical Trauma Kit Shelter in Place (Intermediate)0487-300-022026-07-22
M6898730003050Medical Trauma Kit Shelter in Place (Advanced)0587-300-032026-07-22
M689HHCTUINK01030Chest Tube Insertion Kit03HHCTUINK012025-06-23
M689HHCTUINK0105030Chest Tube Insertion Kit Cast of 503HHCTUINK01-052025-06-23
M6898810502020Patrol Officer IFAK Intermediate0288-105-022018-09-20

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