FDA.reportPublic FDA data

SPLINT, BUCK'S TRAC, CONVOLUTED, SIZE L

Primary DI
00842430113468
Brand
SPLINT, BUCK'S TRAC, CONVOLUTED, SIZE L
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
371L
Catalog number
371L
Published
2021-01-12
Public version status
New
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
HSPSplint, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSPSplint, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842430113468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430113468008424301134688424301134680842430113468

GMDN Terms#

Term, Definition table
TermDefinition
Traction bootAn orthopaedic device designed as an open boot that is attached and tightly secured with laces or straps to the foot or both feet of the patient so that traction can be applied to the patient's body. It is typically used during an orthopaedic surgical trauma intervention when traction is being applied to a patient's leg or legs when broken leg bones are being drawn apart, repositioned, and set to the correct position, or in conjunction with a traction table for the application of traction to the patient's spine. It is available in various foot sizes and has a solid sole construction that can be securely attached/locked to other components of the table. 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

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

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