FDA.reportPublic FDA data

SHEARGUARD TORSO LIFT COVER, AST, 6/CS

Primary DI
00842430113567
Brand
SHEARGUARD TORSO LIFT COVER, AST, 6/CS
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5817-13
Catalog number
5817-13
Published
2021-08-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430113567PrimaryGS10
00842430114410Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430113567008424301135678424301135670842430113567
00842430114410008424301144108424301144100842430114410

GMDN Terms#

Term, Definition table
TermDefinition
Operating table patient pressure distribution pad, single-useA cushion (e.g., gel-filled, foam) intended to be placed between an operating table mattress or a patient positioner (e.g., torso intraoperative positioner, perineal post) and the patient to distribute the patient's body weight over a large surface area, for the prevention of pressure sores and tissue necrosis on prominent parts of the patient's body when immobilized for extended periods during surgery. It is available in various dimensions and shapes to accommodate various body parts such as the buttocks, shoulders, heels, or the entire body (usually excluding the head). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags#

DUNS number
084527241
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430106989BUTTOCKS STRAP W/ VELCRO6977-7396977-7392018-12-07
00842430109027Avra Smart Hub Powered by BodiTrak2872-102872-102021-06-14
00842430110283AVRA HEAD SECTION 3IN STERIS 3080, 308569403AVH69403AVH2021-06-14
00842430110290AVRA BACK SECTION 3IN STERIS 3080, 308569403AVB69403AVB2021-06-14
00842430110306AVRA FOOT SECTION, 3IN, STERIS 3080, 308569403AVF69403AVF2021-06-14
00842430110641AVRA 3-PC SET 3IN STERIS 3080 308569403AVS69403AVS2021-06-14
00842430111266AVRA WIRELESS TABLET DISPLAY2872-402872-402021-06-14
00842430112553LATERAL SUPPORT PAD ASSEMBLY5338-1005338-1002021-02-01
00842430101663TABLE, ProFx, REFURBISHED6850R6850R2020-09-09
00842430101977TABLE, INSITE, REFURBISHED6844R6844R2020-09-09
00842430115097SLING, REHAB SHOULDER, ABDUCTION8678672020-09-03
00842430112119IMMOBILIZER, SHOULDER, UNIVESAL,W/ STRAP146S146S2020-07-27
00842430100031Allegro Table Refurbished 120V, 60HZ6800R6800R2016-09-15
00842430104022ALUMINUM SIDE RAIL SOCKET539453942018-04-18
00842430104404PIVOTING ARM BOARD W/TEMPUR 2IN535653562018-04-18
00842430104497CMBU RADIOLUCENT DORO ADAPTER5979-3005979-3002018-05-10
00842430104503CMBU RADIOLUCENT MAYFIELD ADAPTER5979-2005979-2002018-05-10
00842430104541COUPLER II RADIOLUCENT DORO ADAPTER5873-3005873-3002018-04-26
00842430104947Levó Protective Arm Sleeve789278922019-03-08
00842430105098PIVOTING ARM BOARD W/TEMPUR 3IN535753572018-04-18

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