FDA.report

ASSY, PAD, ARM BOARD, 3"

Primary DI
00842430100611
Brand
ASSY, PAD, ARM BOARD, 3"
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5366-7000
Catalog number
5366-7000
Device description
Pad for the model 5357 Mizuho OSI Pivoting Armboard. Made with Tempur-Pedic® Medical materials.
Published
2017-05-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FMPProtector, Skin Pressure

Product Code Classifications

CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842430100611PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430100611008424301006118424301006110842430100611

GMDN Terms

TermDefinition
Operating table mattressA foam-filled cushion designed as a component of an operating table to serve as the surface upon which the patient is placed. It is typically filled with high-density polyurethane or a memory foam, and may be an integral part of the table (i.e., removable only with tools) or loosely fitted to the table top (e.g., by way of press studs, Velcro strips, or eyeholes and pegs) and is removable for cleaning. The device is firm, waterproof, and washable using strong disinfectants. It is available as one full-length piece or in sections. This is a reusable device.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius38 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-777-4674CustServ@mizuhosi.com

Regulatory Flags

DUNS number
084527241
Device count
1
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
true
Sterilization required before use
false

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