FDA.report

PENTAX

Primary DI
84961333239753
Brand
PENTAX
Company
HOYA CORPORATION
Model
OE-A60
Device description
PENTAX Medical Single Use Balloon OE-A60
Published
2020-09-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ODGEndoscopic ultrasound system, gastroenterology-urology

Product Code Classifications

CodeDeviceSpecialtyClass
ODGEndoscopic Ultrasound System, Gastroenterology-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04961333239757PrimaryGS10
84961333239753Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04961333239757049613332397574961333239757
8496133323975384961333239753

GMDN Terms

TermDefinition
Body-orifice ultrasound imaging transducer cover, basic, sterileA sterile sheath intended to be used as a physical barrier for protection against the effects of environmental exposure (e.g., body fluids, gliding creams) and/or to maintain the required hygienic level of an ultrasound imaging system transducer (probe) used in natural body orifices (e.g., vagina, rectum, oesophagus) during an ultrasound examination; it has no additional functionality. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
691519705
Device count
20
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04961333255191VIVIDEOCP-10002025-12-19
04961333255245VIVIDEOVNL9-CP2025-12-19
04961333255818INSPIRAEPK-i8020c2025-06-20
04961333255832INSPIRAEPK-i8020c2025-06-20
04961333356478PENTAX MedicalEC38-i20cWL2025-04-28
84961333253919PENTAXOE-A522025-04-08
04961333129430PENTAXEC-3890Li2025-04-04
04961333172085PENTAXEC38-i10L2025-04-04
04961333129492PENTAXEG-2990i2025-04-04
04961333211692PENTAXEG29-i102025-04-04
04961333251070PENTAXOF-B1942025-04-04
84961333253902PENTAXOE-A512025-04-04
84961333253933PENTAXOE-A602025-04-04
84961333253957PENTAXOF-A672025-04-04
04961333254620PENTAX MedicalOE-B172024-12-13
04961333356393PENTAX MedicalEG27-i20c2024-12-13
04961333356416PENTAX MedicalEC34-i20cL2024-12-13
04961333356331PENTAX MedicalED34-i10T2s2024-09-03
04961333254781PENTAXEC-2990Li2024-07-26
04961333254460PENTAXEC34-i10L2024-07-26

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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
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