Short Style Endocavity Biopsy Starter Kit

Primary DI: 00841912104239
Brand: Short Style Endocavity Biopsy Starter Kit
Company: PROTEK MEDICAL PRODUCTS, INC.
Model: 7384
Device description: Stainless Steel Endocavity Biopsy Starter Kit for Hitachi EUP-V53W & EUP-CC531 Ultrasound Transducers
Published: 2016-09-16
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true
OTC: false
Sterile: false
Single use: false

Related Records

Identifiers And Packaging

Identifier	Type	Agency	Package quantity	Status
00841912104239	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00841912104239	00841912104239	841912104239	0841912104239

GMDN Terms

Term	Definition
Body-orifice ultrasound imaging transducer cover, basic, non-sterile	A non-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.

Term

Definition

Body-orifice ultrasound imaging transducer cover, basic, non-sterile

A non-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.

Storage And Handling

Type	Low	High	Condition
Storage Environment Temperature	15 Degrees Celsius	30 Degrees Celsius

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number: 965417181
Device count: 1
DM exempt: false
Premarket exempt: false
HCT/P: false
Kit: true
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: true
No natural rubber latex: false
Sterilization required before use: true

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