FDA.reportPublic FDA data

Assy, Head Halter and Chin Cup

Primary DI
00842430106194
Brand
Assy, Head Halter and Chin Cup
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
339
Catalog number
339
Published
2019-01-18
Public version status
Update
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
HSSHalter, Head, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSSHalter, Head, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430106194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430106194008424301061948424301061940842430106194

GMDN Terms#

Term, Definition table
TermDefinition
Traction system head halterA device designed to provide traction to the cervical vertebrae by pulling the head with force from an external traction system. It typically combines several padded straps in a lightweight structure; usually one of the straps is placed under the chin, a second one on the back of the head, and another strap goes around the neck to attach the two other straps together. The device includes one or more rings at the top that permit its attachment to the traction system's cable. It is intended for horizontal and/or vertical traction and is used in orthopaedic and/or physical therapy procedures, including fracture treatment and widening of the intervertebral spaces in the spine.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00842430105166Trios/OTS TRACTION EXTENSION LONG5855-1935855-1932018-04-26
00842430105357GM BOARD LEFT PAD5855-2875855-2872018-05-10
00842430105371GM BOARD RIGHT PAD5855-2865855-2862018-05-10
00842430105739Trios/OTS FOOT-END DRAPE HANGER POST5855-6175855-6172018-05-03
00842430105746Trios/OTS HEAD-END DRAPE HANGER POST5855-6155855-6152018-05-03
00842430105920PIVOTING ARM BOARD ASSY W/OUT PAD5362-65362-62018-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00749756013154DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013161DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013109DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013116DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013123DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013130DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013147DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
50749756013159DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
50749756013166DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756013208DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756015608DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756015615DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-29
00749756878449DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-07-20
00749756031547DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-06-30
50749756031542DeRoyalDEROYAL INDUSTRIES, INC.HSS2021-06-30
10724995165076NASTERIS CORPORATIONHSS2021-04-23
00724995165079NASTERIS CORPORATIONHSS2021-04-23
00889024373518NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.HSS2021-03-03
00889024373587NAZIMMER ORTHOPAEDIC SURGICAL PRODUCTS, INC.HSS2021-03-03
00822383102986DRIVEMEDICALDrive Devilbiss HealthcareHSS2019-06-21
00822383302980DRIVEMEDICALDrive Devilbiss HealthcareHSS2019-06-21
00822383561738DriveDrive Devilbiss HealthcareHSS2019-06-21
00842430106200DISPOSABLE HEAD HALTERMIZUHO ORTHOPEDIC SYSTEMS, INC.HSS2018-10-17
10842430106207HEAD HALTER, DISPOSABLE MIZUHO ORTHOPEDIC SYSTEMS, INC.HSS2018-10-17