FDA.reportPublic FDA data

N/A

Primary DI
04961333241156
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
80254
Device description
DUAL SCOPE HOLDER FOR 80247
Published
2018-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333241156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333241156049613332411564961333241156

GMDN Terms#

Term, Definition table
TermDefinition
Medical monitor/light standA mobile device designed to support a light and/or an image display monitor that is used for medical purposes [e.g., in an operating room (OR) and/or an examination/treatment room]. It is a mobile floor stand which may include wheels and/or articulated arms to enable dynamic positioning; the device to be supported (medical light/monitor) is not included.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04961333225262DEFINAEPK-3000-US2018-04-16
04961333230594N/A9122D2017-04-06
04961333232154VIDEO BRONCHOSCOPEEB-1170K2017-04-06
04961333232161VIDEO BRONCHOSCOPEEB-1570K2017-04-06
04961333232178VIDEO BRONCHOSCOPEEB-1575K2017-04-06
04961333232185VIDEO BRONCHOSCOPEEB-1970K2017-04-06
04961333232192VIDEO BRONCHOSCOPEEB-1970TK2017-04-06
04961333232208ULTRASOUND BRONCHOSCOPEEB-1970UK2017-04-06
04961333232215VIDEO BRONCHOSCOPEEB-1975K2017-04-06
04961333232222VIDEO BRONCHOSCOPEEB-1990I2017-04-06
04961333232239VIDEO COLONOSCOPEEC-2990LI2017-04-06
04961333232253VIDEO COLONOSCOPEEC-3490LI2017-04-06
04961333232260VIDEO COLONOSCOPEEC-3490LK2017-04-06
04961333232277VIDEO COLONOSCOPEEC-3490TLI2017-04-06
04961333232284VIDEO COLONOSCOPEEC34-I10L2017-04-06
04961333232345VIDEO COLONOSCOPEEC-3890LI2017-04-06
04961333232352VIDEO COLONOSCOPEEC-3890LK2017-04-06
04961333232369VIDEO COLONOSCOPEEC-3890LZI2017-04-06
04961333232376VIDEO COLONOSCOPEEC-3890TLK2017-04-06
04961333232383VIDEO COLONOSCOPEEC38-I10L2017-04-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840178704863ITDTouchpoint Medical, Inc.BZN2026-08-03
00840178704122ITDTouchpoint Medical, Inc.BZN2026-07-07
00840456206768JMUJMU DENTAL, INCBZN2026-06-23
00840456206775JMUJMU DENTAL, INCBZN2026-06-23
00840178704801ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704818ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704825ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704832ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704849ITDTouchpoint Medical, Inc.BZN2026-06-10
00840178704702ITDTouchpoint Medical, Inc.BZN2026-05-14
00840178704658ITDTouchpoint Medical, Inc.BZN2026-05-07
06972077026419ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
06972077026426ALLICAREXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-05-07
G035X1BT70M0MULTIX SOLUTIONS SRLMULTIX SOLUTIONS SRLBZN2026-04-28
00840178704627ITDTouchpoint Medical, Inc.BZN2026-04-13
06972077025955ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025962ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025979ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025986ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077025993ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026006ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026013ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026020ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026037ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026044ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026051ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026068ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026075ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026082ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26
06972077026099ACCUCARTXIAMEN TAFT MEDICAL CO.,LTD.BZN2026-03-26