FDA.reportPublic FDA data

PERFORMANCE HEALTH

Primary DI
00840216112315
Brand
PERFORMANCE HEALTH
Company
Asp Global, LLC
Model
A545800
Device description
Rolyan Shoulder Immobilizer, X-Small
Published
2022-05-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NODBoard, Arm (With Cover), Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NODBoard, Arm (With Cover), Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840216112315PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840216112315008402161123158402161123150840216112315

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
080361159
Device count
1
Premarket exempt
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840216129245PRIMOSC101P-K2026-05-21
00840216129252PRIMOSC201P-K2026-05-21
00840216129269ASP GLOBAL PRIMOAFOVERLAY-B-K2026-05-21
00840216129276ASP GLOBAL PRIMOAFOVERLAY-A-K2026-05-21
00840216120037ASP MEDICAL1038SM-ASP2022-08-08
00840216120044ASP MEDICAL1038LG-ASP2022-08-08
00840216120051ASP MEDICAL1038XL-ASP2022-08-08
00840216120068ASP MEDICAL10382XL-ASP2022-08-08
00840216117600ASP MEDICAL1206BG22022-05-09
00840216118171ASP MEDICAL1207BG22022-05-09
00840216118188ASP MEDICAL1208BG22022-05-09
00840216118195ASP MEDICAL1206BG2B2022-05-09
00840216119444ASP MEDICAL1210BG22022-05-09
00840216105423ASP MEDICALRGPA6102022-09-19
00840216102705ASP MEDICALRGPA610SL2022-08-23
00840216102644ASP MEDICALHIA1022022-08-15
00840216106659ASP MEDICALHIA4112022-08-15
00840216119291ASP MEDICALINFHW-ASP2022-08-15
00840216119505ASP MEDICALINFHWD-ASP2022-08-15
00840216101821ASP MEDICALIWA012022-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840118400630MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400647MTIMedical Technology Industries, Inc.NOD2022-12-30
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10840118400661MTIMedical Technology Industries, Inc.NOD2022-12-30
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10840118400791MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400807MTIMedical Technology Industries, Inc.NOD2022-12-30
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10840118400821MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400838MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400845MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400852MTIMedical Technology Industries, Inc.NOD2022-12-30
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10840118400876MTIMedical Technology Industries, Inc.NOD2022-12-30
10840118400883MTIMedical Technology Industries, Inc.NOD2022-12-30