FDA.reportPublic FDA data

PROTECTOR, NERVE, ULNAR/BRACHIAL

Primary DI
00842430113246
Brand
PROTECTOR, NERVE, ULNAR/BRACHIAL
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
10305
Catalog number
10305
Published
2020-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMPProtector, Skin Pressure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMPProtector, Skin PressureGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430113246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430113246008424301132468424301132460842430113246

GMDN Terms#

Term, Definition table
TermDefinition
Elbow protectorA device that is designed to be worn over the elbow to provide a cushion to protect the elbow from friction against surfaces and knocks against objects. It is typically made from soft padded materials and is held in place with bands or straps around the arm. It is typically used by persons that have tendencies for skin sores on their elbows, are bedridden, or prone to lack of control with their arms causing injury. This is a reusable device.

Sterilization Methods#

Method table
Method

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
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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