FDA.report

PERFORMANCE HEALTH

Primary DI
00840216112278
Brand
PERFORMANCE HEALTH
Company
ASP GLOBAL, LLC
Model
A545802
Device description
Rolyan Shoulder Immobilizer, Medium
Published
2022-05-24
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
NODBoard, Arm (With Cover), Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NODBoard, Arm (With Cover), Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840216112278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216112278008402161122788402161122780840216112278

GMDN Terms

TermDefinition
Shoulder immobilizer, reusableA non-rigid device used to temporarily immobilize or limit abduction of the shoulder joint to support healing of an injury or a surgical wound. It is typically used postoperatively and for post traumatic treatment of injuries in the shoulder and upper arm areas (e.g., distortion/contusion, dislocation/luxation, and postoperative support). It will typically consist of layered fabric, straps, buckles, fasteners and will eliminate most of the work involved with bandaging. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080361159
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840216128262ASP GLOBALEGT3052025-11-20
00840216128286ASP GLOBALEGT3072025-11-20
00840216128804ASP GLOBAL PRIMOAFTS012025-06-30
00840216128279ASP GLOBALEGT3062025-06-17
00840216128293ASP GLOBALEGT3082025-06-17
00840216128842CARDINAL HEALTH AD6X10BILH2025-06-17
00840216128606LAPCORP LC4X6EZQ2025-05-13
00840216128613LAPCORP LC9X12MTL2025-05-13
00840216128163QUEST DIAGNOSTICSQD6.75X11AD2024-11-22
00840216127753ASP MEDICALMRT8002024-09-12
00840216128033ASP MEDICALMRACUP12024-09-12
20840216127566PRIMOAFTMATT2024-08-12
00840216120808PRIMOGGS3660TBH-K2024-03-05
00840216120853PRIMOGGS5670TBH-K2024-03-05
00840216121898PRIMOGGTS142024-03-05
00840216124509PRIMOGGTS13-K2024-03-05
00840216124516PRIMOGGTS14-5-K2024-03-05
00840216122697PRIMOAFPUMP2024-03-01
00840216125124PRIMOHB2002024-03-01
00840216125131PRIMOHB200B2024-03-01

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00810082221534Soule MedicalSOULE CO., THENOD2023-07-06
10766923025212Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025229Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10766923025236Pedi BoardPEDICRAFT, INC.NOD2023-06-07
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10766923025304Pedi BoardPEDICRAFT, INC.NOD2023-06-07
10840118405246MTIMedical Technology Industries, Inc.NOD2023-04-28
10840118429303MTIMedical Technology Industries, Inc.NOD2023-04-28
06943718240013DemaxBeijing Demax Medical Technology Co., Ltd.NOD2023-02-13
06943718240020DemaxBeijing Demax Medical Technology Co., Ltd.NOD2023-02-13
06943718244103DemaxBeijing Demax Medical Technology Co., Ltd.NOD2023-02-13
00733657244786ACS DISPOSABLE 30/CSALIMED, INC.NOD2022-12-01
00733657244793ACS W/ STRAP (12/CS)ALIMED, INC.NOD2022-12-01
00840216112285PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00840216112292PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00840216112308PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00840216112315PERFORMANCE HEALTHASP GLOBAL, LLCNOD2022-05-24
00653405001730NAConmed CorporationNOD2021-10-06
10810030863318NAMID CENTRAL MEDICAL CORP.NOD2021-09-20
10810030863325NAMID CENTRAL MEDICAL CORP.NOD2021-09-20
10810030861437NAMID CENTRAL MEDICAL CORP.NOD2020-09-30
10810030861444NAMID CENTRAL MEDICAL CORP.NOD2020-09-30
10810030861451NAMID CENTRAL MEDICAL CORP.NOD2020-09-30
10810030861468NAMID CENTRAL MEDICAL CORP.NOD2020-09-30