FDA.reportPublic FDA data

Ultramatrix EUS Linear Balloon for Olympus

Primary DI
00864390000336
Brand
Ultramatrix EUS Linear Balloon for Olympus
Company
N. M. BEALE COMPANY, INC.
Model
USB-OL
Catalog number
USB-OL
Published
2016-12-07
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864390000336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864390000336008643900003368643900003360864390000336

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound endoscope balloon, synthetic polymerA sterile balloon-like cap made of a synthetic-polymer (e.g., silicone) designed to be placed on the distal end of an ultrasound endoscope and inflated to make contact with the wall of the viscus to enable a higher-quality ultrasound image during echo-endoscopy, typically of the gastrointestinal or respiratory tract. It is inflated with water through the endoscope. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-989-9558bealeco@verizon.net

Regulatory Flags#

DUNS number
780056289
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864390000312Clear Fit Scope Introducer740074002016-12-07
00864390000305Baleen Polyp TrapNBPT520NBPT5202016-12-07
00864390000329EZ-MISTER Disposable AtomizerEZ24EZ242016-12-07
00864390000343Ultramatrix EUS Linear Balloon for PentaxUSB-PLUSB-PL2016-12-07
00864390000350Ultramatrix EUS Radial Balloon for Olympus & PentaxUSB-ORUSB-OR2016-12-07
00864390000367N-Doe PillowNDPNDP2017-03-02

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