FDA.reportPublic FDA data

Sterile Disposable Endocavity Needle Guide Kit

Primary DI
00841912105274
Brand
Sterile Disposable Endocavity Needle Guide Kit
Company
PROTEK MEDICAL PRODUCTS, INC.
Model
5562
Catalog number
5562
Device description
Sterile Disposable Endocavity Needle Guide Kit for use with Toshiba PVT-781VT, PVU-781VT & 11C3 Ultrasound Transducers
Published
2017-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ITXTransducer, Ultrasonic, Diagnostic
KKXDrape, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITXTransducer, Ultrasonic, DiagnosticRadiology2
KKXDrape, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K970891000
K971115000
K971722000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K970891000DRAPE, SURGICAL-LATEXProtek Medical Products, Inc.1997-08-22KKX
K971115000GE MEDICAL-NEEDLE GUIDE FOR SV, TR ANDATF, ACUSON-NEEDLE GUIDEProtek Medical Products, Inc.1997-06-13ITX
K971722000TRANS VAGINAL NEEDLE GUIDEProtek Medical Products, Inc.1997-07-10ITX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10841912105271PackageGS124In Commercial Distribution
00841912105274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084191210527110841912105271
00841912105274008419121052748419121052740841912105274

GMDN Terms#

Term, Definition table
TermDefinition
Body-orifice ultrasound imaging transducer cover, basicA 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.

Regulatory Flags#

DUNS number
965417181
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10841912104717Probe Storage Covers11402021-09-20
00841912100507CT Control Cover100610062016-09-16
00841912100538CT Monitor Cover 100910092016-09-16
00841912100545CT Control Cradle Cover101010102016-09-16
00841912100552System Cover Kit101110112016-09-16
00841912100583Neoprobe Sterile Sleeve Kit with PullUp/pull off extension102710272016-09-16
00841912100590System Drape102810282016-09-16
00841912100606PullUp Instrument Cover103010302016-09-16
00841912100637RTP Universal Stepper/Stabilizer Drape12022016-09-16
00841912100644System Drape Kit121212122016-09-16
00841912100651System Drape Kit121312132016-09-16
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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08800290029376CA2-13MSAMSUNG MEDISON CO., LTD.ITX2026-08-18
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10801902196665ARROWTELEFLEX INCORPORATEDKKX2026-07-28
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00841436124294Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
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00841436126052Biopsy BracketCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27
00841436126403Needle Guide Starter KitCIVCO MEDICAL INSTRUMENTS CO., INC.ITX2026-07-27