FDA.reportPublic FDA data

27" SOFT- STRAP, ARMBOARD STRAP

Primary DI
00842430114212
Brand
27" SOFT- STRAP, ARMBOARD STRAP
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5917
Catalog number
5917DZ
Published
2020-09-09
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMQRestraint, Protective

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMQRestraint, ProtectiveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430113871PrimaryGS10
00842430114212Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430113871008424301138718424301138710842430113871
00842430114212008424301142128424301142120842430114212

GMDN Terms#

Term, Definition table
TermDefinition
Limb/torso/head restraint, single-useA non-rigid device, typically a strap(s) or band(s), intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
084527241
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842430116261KIT, HANA SSXT MAQUET 1140 VERSION687668762023-01-17
00842430113093KIT, HANA SSXT-HIP ARTHROSCOPY UNIT687468742022-05-19
00842430103155HANA SSXT- AA THA UNIT, MOT, JP RAILS6879-16879-12022-02-14
00842430103162Hana SSXT- AA THA Unit, MOT, EU Rails6879-26879-22022-02-14
00842430111365HANA SSXT- AA THA UNIT REFURB6870R6870R2022-02-11
00842430113086HANA SSXT- AA THA UNIT687068702022-02-11
00842430114236HANA SSXT-HIP ARTHROSCOPY UNIT, LIFEHEALTHCARE IMAGE 777687368732022-02-11
00842430106484ProFx TRACTION BOOT ADAPTOR ASSY6850-276850-272019-04-02
00842430108914PATIENT TRANSFER ASSY6875-7426875-7422019-04-02
00842430106415Hana/ProFx LATERAL PERINEAL POST6850-4006850-4002018-10-17
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

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