Biopsy Starter Kit

Primary DI
00841912106400
Brand
Biopsy Starter Kit
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
7277
Device description
Biopsy Starter Kit for Mindray L12-4s, 7L4s, L14-6Ns, L14-6NE & L12-3E Ultrasound Transducers
Published
2020-03-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841912106295Direct MarkingGS10
00841912106400PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841912106295008419121062958419121062950841912106295
00841912106400008419121064008419121064000841912106400

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system tracking positioner, reusableA metal or plastic bracket intended to be applied to a hand-held ultrasound (US) transducer for the repeatable positioning (detach from/reattach to same place) of an electromagnetic (EM) sensor and/or needle guide on the transducer. It may be used in conjunction with an EM device tracking system and is intended for applications involving needle guidance and tracking such as ablation, core tissue biopsy, fluid aspiration, therapeutic delivery and vascular access. Disposable needle guides and imaging-supportive devices (e.g., US transducer cover/gel) may be included with the positioner; the transducer and sensor are not included. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

DUNS number
965417181
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

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