FDA.reportPublic FDA data

HEAD HALTER, DISPOSABLE

Primary DI
10842430106207
Brand
HEAD HALTER, DISPOSABLE
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
342-2
Catalog number
342
Published
2018-10-17
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
HSSHalter, Head, Traction

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842430106207PackageGS112In Commercial Distribution
00842430106200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084243010620710842430106207
00842430106200008424301062008424301062000842430106200

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
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
00842430117312ADANTE DURABLE BODY STRAP, NO HOOK6895-13656895-13652026-04-17
00842430116667ADANTE PELVIC CENTER POSTLESS PAD6895-13066895-13062025-07-04
00842430116735ADANTE ADAPTER, MAI CLARK SOCKET6895-21906895-21902026-03-31
00842430116766 WELL LEG SUPPORT, SHORT5855-838S5855-838S2026-03-31
00842430116742PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
00842430116759PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
10842430116749PKIT, STS Trios, LPC, SG ARM PAD5808PC-12026-01-21
10842430116756PKIT PROAXIS LPC SG HIP ARM6988A-PC-12026-01-21
00842430101717TABLE, INSITE684468442020-09-09
00842430107450INSITE TABLE, 230V6844i6844i2020-09-09
00842430107467TABLE, ProFx, 230 VOLT6850i6850i2020-09-09
00842430112102TABLE, ProFx685068502020-09-09
00842430114601TABLE, INSITE, 100V6844J6844J2020-09-08
00842430100017Allegro Imaging Table 120V, 60HZ680068002016-09-13
00842430100024Allegro Imaging Table 220-230V, 50/60HZ6800I6800I2016-09-15
00842430109188PRONECONNECT PROTECTIVE HELMETPC501FHPC501FH2025-08-29
00842430109195PRONECONNECT ADJUSTABLE HELMETPC502AHPC502AH2025-08-29
00842430109201PRONECONNECT COMBO PACK 4L, 3M, 3SPC-COMBOPC-COMBO2025-08-29
00842430109218PRONECONNECT LOW PROFILE MIRRORPC520MPC520M2025-08-29
00842430109225PRONECONNECT ADJUSTABLE MIRRORPC590MPC590M2025-08-29

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
00842430106194Assy, Head Halter and Chin CupMIZUHO ORTHOPEDIC SYSTEMS, INC.HSS2019-01-18
00842430106200DISPOSABLE HEAD HALTERMIZUHO ORTHOPEDIC SYSTEMS, INC.HSS2018-10-17