FDA.report

Coupler II Main Assembly

Primary DI
00842430104534
Brand
Coupler II Main Assembly
Company
MIZUHO ORTHOPEDIC SYSTEMS, INC.
Model
5873
Catalog number
5873
Published
2018-05-04
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

Related Records

Product Codes

CodeName
JEATable, Surgical With Orthopedic Accessories, Ac-Powered

Product Code Classifications

CodeDeviceSpecialtyClass
JEATable, Surgical With Orthopedic Accessories, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842430104534PrimaryGS10

GMDN Terms

TermDefinition
Head/neck procedure positionerA noninvasive device consisting of fixed or adjustable elements (e.g., frame, board, multi-jointed structure) designed to ensure adequate support, positioning and immobilization of the patient's head, neck, and cervical spine during intraoperative procedures (e.g., cervical spine or brain surgery) or diagnostic imaging (e.g., dental x-ray procedures). It is typically mounted on an operating/examination table and allows adjustment of the height and angle of the head. 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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