FDA.reportPublic FDA data

CRADLE SLING ECONOMY

Primary DI
10609271020730
Brand
CRADLE SLING ECONOMY
Company
DARCO INTERNATIONAL, INC.
Model
422-0025-30
Catalog number
422-0025-30
Device description
Small
Published
2023-02-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
10609271020730PackageGS14In Commercial Distribution
20609271020737PackageGS112In Commercial Distribution
00609271020733PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927102073010609271020730
2060927102073720609271020737
00609271020733006092710207336092710207330609271020733

GMDN Terms#

Term, Definition table
TermDefinition
Arm immobilizerA non-rigid device, usually made of a fabric, used to temporarily render the arm immovable, typically at the shoulder and elbow, to support healing of an injury or a surgical wound. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20609271989607Aircore™ InsoleACIP0602026-01-07
20609271989614Aircore™ InsoleACIP0702026-01-07
20609271989621Aircore™ InsoleACIP0752026-01-07
20609271989638Aircore™ InsoleACIP0802026-01-07
00609271989641Aircore™ InsoleACIP0852026-01-07
20609271989652Aircore™ InsoleACIP0902026-01-07
20609271989669Aircore™ InsoleACIP0952026-01-07
20609271989676Aircore™ InsoleACIP1002026-01-07
20609271989683Aircore™ InsoleACIP1052026-01-07
20609271989690Aircore™ InsoleACIP1102026-01-07
20609271989706Aircore™ InsoleACIP1152026-01-07
20609271989713Aircore™ InsoleACIP1202026-01-07
20609271989720Aircore™ InsoleACIP1252026-01-07
20609271989737Aircore™ InsoleACIP1302026-01-07
20609271989744Aircore™ InsoleACIP1352026-01-07
20609271989751Aircore™ InsoleACIP1452026-01-07
20609271989768Aircore™ InsoleACIP1552026-01-07
00609271120167POGO™ PulsusPGP060NPGP060N2025-04-15
00609271120174POGO™ PulsusPGP070NPGP070N2025-04-15
00609271120181POGO™ PulsusPGP075NPGP075N2025-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16974500613613Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
16974500613620Arm SlingGCMEDICA ENTERPRISE LTD.(WUXI)ILI2025-12-12
00810113683027Shoulder Brace with Airplane KitManamed, Inc.ILI2025-09-19
00810113683034Shoulder Brace with Airplane Kit LOGOManamed, Inc.ILI2025-09-19
00190446660354PROCAREDJO, LLCILI2025-07-14
50749756397846DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-27
00749756397285DeRoyalDEROYAL INDUSTRIES, INC.ILI2025-02-13
00840314811097UNIV ARM SLING W/FOAM STRAP ADULTHausmann Enterprises, LLCILI2025-01-01
10810113576944CoreTechVIVE HEALTH LLCILI2024-06-10
10057475611023BIOS LivingThermor LtdILI2024-05-23
00888912014366DONJOYDJO, LLCILI2024-02-27
07798094540061WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540078WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540085WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540092WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540108WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540115WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540511WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540528WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540535WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094540542WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094541105WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094541624WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547770WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547787WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547794WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547879WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547886WELLBRACEPANTYMED S.A.ILI2024-01-05
07798094547893WELLBRACEPANTYMED S.A.ILI2024-01-05
07798128672034WELLBRACEPANTYMED S.A.ILI2024-01-05