FDA.report

CRADLE SLING ECONOMY

Primary DI
20609271020751
Brand
CRADLE SLING ECONOMY
Company
DARCO INTERNATIONAL, INC.
Model
422-0025-40
Catalog number
422-0025-40
Device description
Medium
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

Related Records

Product Codes

CodeName
ILISLING, ARM

Product Code Classifications

CodeDeviceSpecialtyClass
ILISling, ArmPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10609271020754PackageGS14In Commercial Distribution
20609271020751PackageGS112In Commercial Distribution
00609271020757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927102075410609271020754
2060927102075120609271020751
00609271020757006092710207576092710207570609271020757

GMDN Terms

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

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

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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 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