FDA.reportPublic FDA data

N/A

Primary DI
04961333230334
Brand
N/A
Company
PENTAX OF AMERICA, INC.
Model
9175
Device description
Isolation Transformer
Published
2017-04-07
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
GCWTransformer, Endoscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCWTransformer, EndoscopeGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04961333230334PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04961333230334049613332303344961333230334

GMDN Terms#

Term, Definition table
TermDefinition
Constant-voltage transformerA device designed to deliver a fixed, predetermined voltage that is one of a limited range of input voltage variations. The device receives a fluctuating input voltage and transforms this fluctuating voltage into a steady (constant) output helping to avoid such fluctuations which are present in the electrical system. These fluctuations may be known as spikes, and can be harmful to devices with sensitive electronics. This device may be inserted into new or existing electrical systems.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
083211284
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854924006255C2 CryoBalloon Ablation System FG-10252025-04-04
00854924006293C2 CryoBalloon Ablation SystemFG-10292025-04-04
04961333255313C2 CryoBalloonFG-10552024-09-12
04961333255320C2 CryoBalloonFG-10562024-09-12
04961333248445C2 CryoBalloon NitroclipFG-10502020-08-07
00854924006408C2 CryoBalloon EndoGripFG-10402020-07-29
04961333232550ULTRASOUND GASTROSCOPEEG-3670URK2017-04-06
04961333232567ULTRASOUND GASTROSCOPEEG-3870UTK2017-04-06
04961333233953ULTRASOUND GASTROSCOPEEG-3270UK2017-06-26
04961333231942VIDEO PROCESSOREPK-I5010-US2018-04-16
04961333232598VIDEO PROCESSOREPK-I50102017-04-06
04961333232604VIDEO PROCESSOREPK-I70102017-04-06
04961333242207N/A92026/102018-03-08
04961333242214N/A92026/252018-03-08
04961333242221N/A92026/32018-03-08
04961333242238N/A92026/502018-03-08
04961333242276N/A92052/202018-03-08
04961333242283N/A92052/62018-03-08
04961333242306N/A92092/122018-03-08
04961333242313N/A92092/252018-03-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00732094073683Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094073898Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094074109Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-08-16
00732094147629Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094144086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2023-04-25
00732094136715Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094136722Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094136760Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00732094174021Welch Allyn, Inc.WELCH ALLYN, INC.GCW2021-05-05
00304040090664Henry ScheinHENRY SCHEIN, INC.GCW2021-04-23
00732094342055Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342079Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342130Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342154Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342031Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342048Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342062Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342086Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342093Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342109Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342116Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342123Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342147Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342161Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342178Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094342185Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-12
00732094341805Welch Allyn, Inc.WELCH ALLYN, INC.GCW2020-11-10