FDA.report

BUCK'S TRACTION SP W/CONVOLUTED FOAM, XS

Primary DI
00842430114366
Brand
BUCK'S TRACTION SP W/CONVOLUTED FOAM, XS
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
371XS
Catalog number
371XS
Published
2021-07-21
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
true

Related Records

Contact Domains

Product Codes

CodeName
HSPSplint, Traction

Product Code Classifications

CodeDeviceSpecialtyClass
HSPSplint, TractionOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842430114366PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842430114366008424301143668424301143660842430114366

GMDN Terms

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

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
false
Sterilization required before use
false

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