FDA.reportPublic FDA data

Ultramatrix

Primary DI
10724995180772
Brand
Ultramatrix
Company
US Endoscopy
Model
USBOR
Catalog number
USBOR
Device description
Ultramatrix EUS balloon-Olympus Pentax radial is used for endoscopic ultrasound applications using the balloon method in the gastrointestinal tract.
Published
2020-04-02
Public version status
New
Distribution status
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
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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
10724995180772PackageGS120In Commercial Distribution
00816765014332PreviousGS10
00724995180775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499518077210724995180772
00816765014332008167650143328167650143320816765014332
00724995180775007249951807757249951807750724995180775

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
Special Storage Condition, Specify00Keep Dry
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00724995182557Exacto00711094007110942021-03-31
00724995182564Exacto00711095007110952021-03-31
00724995182618Exacto00711115007111152021-03-31
00724995243746Exacto Mundo00711114007111142025-01-31
00724995180959VIA00717001007170012020-01-31
00724995181116VIA00717019007170192020-01-30
00724995181420VIA00717051007170512020-01-30
00724995181451VIA00717054007170542020-01-30
00724995181505VIA00717059007170592020-01-30
00724995181659VIA00717076007170762020-01-30
00724995182984VIA00717141007171412020-01-30
00724995183073VIA00717155007171552020-07-16
00724995183141VIA00717167007171672020-01-30
00724995183257VIA00717182007171822020-01-30
00724995190699VIA00717223007172232020-01-30
00724995190736VIA00717234007172342020-01-30
00724995193966VIA00717269007172692020-02-04
00724995194123VIA00717229007172292020-02-07
00724995194987VIA00717310007173102020-03-23
00724995203412VIA00717337007173372020-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850050934240EndoSound® EVS SideBeam 5103Endosound, Inc.ODG2026-06-01
00850050934257EndoSound® Coax Transducer Extension Connector (TEC)Endosound, Inc.ODG2026-06-01
00850050934264EndoSound® EVS SideBeam 5105 (4 pouches)Endosound, Inc.ODG2026-06-01
04953170467288ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.ODG2026-01-21
04953170467318ULTRASONIC PROBEOLYMPUS MEDICAL SYSTEMS CORP.ODG2026-01-21
04953170410178EVIS EUS ULTRASOUND GASTROINTESTINAL VIDEOSCOPEOLYMPUS MEDICAL SYSTEMS CORP.ODG2025-11-19
04953170467356EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE OLYMPUS GF TYPE UCT180OLYMPUS MEDICAL SYSTEMS CORP.ODG2025-09-25
06932503534703Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534727Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534734Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534741Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534772Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534789Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534819Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534826Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534864Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
06932503534888Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534700Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534724Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534731Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534748Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534779Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534786Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534816Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534823Areus(TM) Endoscopic Ultrasound Aspiration Needle (FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534861Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
16932503534885Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle(FNA)Micro-Tech (Nanjing) Co., Ltd.ODG2025-04-30
04953170467271PROBE DRIVING UNITOLYMPUS MEDICAL SYSTEMS CORP.ODG2025-04-16
04961333253906PENTAXHOYA CORPORATIONODG2025-04-04
04961333253937PENTAXHOYA CORPORATIONODG2025-04-04