FDA.reportPublic FDA data

ACS W/ STRAP (12/CS)

Primary DI
00733657244793
Brand
ACS W/ STRAP (12/CS)
Company
ALIMED, INC.
Model
95-985
Catalog number
2970017617
Published
2022-12-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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
00733657244793PrimaryGS10
00733657299649Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00733657244793007336572447937336572447930733657244793
00733657299649007336572996497336572996490733657299649

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding patient positioner, single-useA preformed patient-contact device (e.g., cushion, pad, bolster, wedge, elevation pillow) designed to be placed freely on a flat surface (e.g., operating table, stretcher) to position and stabilize a patient or body part typically in preparation for and during various medical procedures [e.g., to align the head, neck and thorax to optimise laryngoscopy in anaesthesia]; it is not attached to a parent device. It is made of shock-absorbing materials (e.g., memory foam) to reduce pressure on the bony prominences of a body part (e.g., torso, arm, leg), and some types are inflatable to provide variable support (e.g., to level the spine in a lateral position). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(781)329-2900customerservice@alimed.com

Regulatory Flags#

DUNS number
056007248
Device count
12
DM exempt
true
Premarket exempt
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00733657221923WRST ELASTIC FRDM LONG XXSM/RT572829700035922022-12-01
00733657221930WRST ELASTIC FRDM LONG XXSM/LF572929700035932022-12-01
00733657221947WRST ELASTIC FRDM LONG RT/XSM573029700035942022-12-01
00733657221954WRST ELASTIC FRDM LONG LF/XSM573129700035952022-12-01
00733657221961WRIST ELASTIC FRDM LONG RT/SM573229700035962022-12-01
00733657221978WRIST ELASTIC FRDM LONG LF/SM573329700035972022-12-01
00733657221985WRIST ELASTIC FRDM LONG RT/MD573429700035982022-12-01
00733657221992WRIST ELASTIC FRDM LONG LF/MD573529700035992022-12-01
00733657222005WRIST ELASTIC FRDM LONG RT/LG573629700036002022-12-01
00733657222012WRIST ELASTIC FRDM LONG LF/LG573729700036012022-12-01
00733657222029WRIST ELASTIC FRDM LONG RT/XLG573829700036022022-12-01
00733657222036WRIST ELASTIC FRDM LONG LF/XLG573929700036032022-12-01
00733657222074WRIST ELASTIC FRDM SHORT RT/XSM576029700036062022-12-01
00733657222081WRIST ELASTIC FRDM SHORT LF/XSM576129700036072022-12-01
00733657222098WRIST ELASTIC FRDM SHORT RT/SM576229700036082022-12-01
00733657222104WRIST ELASTIC FRDM SHORT LF/SM576329700036092022-12-01
00733657222111WRIST ELASTIC FRDM SHORT RT/MD576429700036102022-12-01
00733657222128WRIST ELASTIC FRDM SHORT LF/MD576529700036112022-12-01
00733657222135WRIST ELASTIC FRDM SHORT RT/LG576629700036122022-12-01
00733657222142WRIST ELASTIC FRDM SHORT LF/LG576729700036132022-12-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840118400647MTIMedical Technology Industries, Inc.NOD2022-12-30
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10840118400661MTIMedical Technology Industries, Inc.NOD2022-12-30
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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