FDA.report

Shoulder Immobilizer

Primary DI
00802357833740
Brand
Shoulder Immobilizer
Company
MEDICAL SPECIALTIES INCORPORATED
Model
183374
Published
2022-12-07
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
false

Related Records

Product Codes

CodeName
ILISling, Arm

Product Code Classifications

CodeDeviceSpecialtyClass
ILISling, ArmPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00802357833740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357833740008023578337408023578337400802357833740

GMDN Terms

TermDefinition
Shoulder immobilizer/orthosis, reusableA prefabricated (non-customized) non-rigid wearable device designed to support, align, and/or temporarily immobilize the shoulder joint to support the healing of an injury or surgical wound. It will typically consist of straps, buckles, fasteners, or be in the form of a sling. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
003173028
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

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00802357172351Gripper 3 Knee, 12" Coolflex1172352025-01-14
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00802357234400EPIGEL W/STAYS, UNIVERSAL2234402025-01-14
00802357240012TRIPOD WRIST LACER II2240012025-01-14
00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14

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
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