FDA.reportPublic FDA data

Ultramatrix

Primary DI
10816765014322
Brand
Ultramatrix
Company
US Endoscopy
Model
USBOL
Catalog number
USBOL
Device description
The Ultramatrix EUS balloon -Olympus linear is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract.
Published
2018-08-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITXTransducer, ultrasonic, diagnostic
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180731000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180731000Ultramatrix EUS BalloonUnited States Endoscopy Group, Inc. (Us Endoscopy)2018-04-19ODG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816765014322PackageGS120Not in Commercial Distribution
00864390000336PreviousGS10
00816765014325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081676501432210816765014322
00864390000336008643900003368643900003360864390000336
00816765014325008167650143258167650143250816765014325

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
627879687
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
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00724995183073VIA00717155007171552020-07-16
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00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

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