FDA.reportPublic FDA data

Reusable Biopsy Bracket

Primary DI
00841912106783
Brand
Reusable Biopsy Bracket
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
6306
Device description
Multi Angle Biopsy Bracket for GE C2-9-D & C2-9-VN-D Ultrasound Transducers
Published
2021-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973958000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973958000GENERAL PURPOSE ATL NEEDLE GUIDE KITProtek Medical Products, Inc.1998-01-22ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841912106783PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841912106783008419121067838419121067830841912106783

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system tracking holder, reusableA metal or plastic bracket manually applied to a hand-held ultrasound (US) transducer intended to provide a means to attach/hold an electromagnetic (EM) sensor or needle guide to the distal end of the US transducer in a repeatable position (can detach/reattach to same place on 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 device. This is a reusable device.

Sterilization Methods#

Method table
Method
High-level Disinfectant

Regulatory Flags#

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

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00841912100637RTP Universal Stepper/Stabilizer Drape12022016-09-16
00841912100644System Drape Kit121212122016-09-16
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00841912100668Isoloader Surgical Drape1214S5521332016-09-16
00841912100675System Drape with Pocket121712172016-09-16
00841912100866Cord Cover Kit194019402016-09-16
00841912104369The Guard Sterile Barrier1205KM12052016-09-16
00841912105021ClingTouch Sterile Disposable Monitor Cover018001802017-09-29
00841912105335Sterile Disposable System Drape Kit128012802017-11-17
00841912105618Terminator XRT Sterile Drape1228TXRT-SD2018-06-06
00841912106035Sterile Sleeve for Gamma Finder III103110312019-06-10
00841912106042System Cover107410742020-11-06

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