FDA.reportPublic FDA data

PILLOW, GENTLETOUCH 7 INCH LT

Primary DI
00842430110085
Brand
PILLOW, GENTLETOUCH 7 INCH LT
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
1941
Catalog number
1941DZ
Published
2020-09-09
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
CCXSupport, Patient Position

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842430110082PackageGS112In Commercial Distribution
00842430110085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084243011008210842430110082
00842430110085008424301100858424301100850842430110085

GMDN Terms#

Term, Definition table
TermDefinition
Freestanding headrest, single-useA device designed to be placed on a flat surface (e.g., operating/examination table, stretcher) to support and stabilize the head of a recumbent patient, typically in preparation for and during many types of medical procedures or examinations; it is not attached to a parent device. The headrest is typically made of shock-absorbing materials (e.g., memory foam, gel) that cushion the head and is available in various sizes and shapes including head pad, head ring, and concave ergonomic holders with fingered lateral supports to position 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
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842430105159Trios/OTS TRACTION EXTENSION SHORT5855-5785855-5782018-04-24

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