Needle Guide 610-1431

GUDID 00841436118293

Reusable non-sterile endocavity needle guide with cleaning brushes (5) for use with Clarius EC7 transducers

CIVCO MEDICAL INSTRUMENTS CO., INC.

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Primary Device ID00841436118293
NIH Device Record Key8567a78b-389d-44fa-88d4-922cae9392df
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeedle Guide
Version Model Number610-1431
Catalog Number610-1431
Company DUNS134614411
Company NameCIVCO MEDICAL INSTRUMENTS CO., INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com
Phone+1(319)248-6502
Emailregulatory@civco.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841436118293 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYOSystem, imaging, pulsed echo, ultrasonic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-29
Device Publish Date2021-11-20

On-Brand Devices [Needle Guide]

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00841436110068Sterile needle guides (1cm, 1.5cm, 2cm depths) with (10.2 x 147cm) CIV-Flex™ cover for use wit
00841436110051Sterile needle guides (1.5cm, 2.5cm, 3.5cm, 4.5cm depths) with (10.2 x 147cm) CIV-Flex™ cover
00841436110037Disposable sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for u
00841436109284Sterile disposable endocavity needle guide REF# 134-181 for use with GE Healthcare IC9-RS transd
00841436109277Sterile disposable endocavity needle guide REF# 134-181 with (2.0 x 20cm) and (3.5 x 20cm) latex
00841436108959Sterile quick-release endocavity needle guide with 10-11GA, 14GA, 16-18GA inserts, (2.6 x 20cm)
00841436108942Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with GE He
00841436108898Sterile quick-release endocavity needle guide with 10-11GA, 14GA, 16-18GA inserts, (2.6 x 20cm)
00841436108881Sterile quick-release endocavity needle guide with 10-11GA, 14GA, 16-18GA inserts for use with G
00841436108195Sterile quick-release endocavity needle guide with 10-11GA, 14GA, 16-18GA inserts for use with G
00841436108188Sterile endocavity needle guide (REF# 134-153) with (3.5 x 20cm) latex covers (2) for use with G
00841436108171Sterile endocavity needle guide (REF# 134-153) for use with GE Healthcare RIC5-9-D, RIC5-9W-RS,
00841436108133Sterile endocavity needle guide for use with GE BE9C and BE9CS transducers
00841436108119Sterile endocavity needle guide for use with GE Healthcare E72, E721, EC8, E8C-RS, E8CS, IC5-9-D
00841436108669Sterile endocavity needle guide with (3.5 x 20cm) latex cover for use with GE Healthcare E72, E7
00841436108096Sterile endocavity needle guide for use with GE Healthcare 7.5 (Ausonics) endorectal transducers
00841436108089Sterile endocavity needle guide (endorectal-medium guide) for use with GE Healthcare TV/TR 618e
00841436108072Sterile endocavity needle guide (long) for use with GE Healthcare TV/TR 618e transducers
00841436108041Sterile endocavity needle guide with (11.9 to 3.8 x 61cm) CIV-Flex™ cover for use with ZONARE
00841436108010Sterile endocavity needle guide with (2.0 x 20cm) and (3.5 x 20cm) latex covers for use with ZON
00841436108003Sterile endocavity needle guide for use with ZONARE E9-4 transducers
00841436107808Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Tos
00841436107792Sterile endocavity needle guide for use with Toshiba PVU-681MVL transducers
00841436107693Sterile endocavity needle guide with (3.2 tapered to 1.9 x 32cm) and (3.5 x 20cm) latex covers f
00841436107686Sterile endocavity needle guide for use with Toshiba PVT-781VT and PVU-781VT transducers
00841436107679Sterile transrectal needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with To
00841436107655Sterile transrectal needle guide for use with Toshiba PVU-770ST transducers
00841436107648Sterile endocavity needle guide for use with Toshiba PVM-740RT and PVT-770RT transducers
00841436107631Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Tos
00841436107624Sterile endocavity needle guide for use with Toshiba PVT-681 MV transducer
00841436107525Sterile transrectal needle guide with (3.2 tapered to 1.9 x 32cm) latex cover for use with Toshi
00841436107433Sterile endocavity needle guide for use with Shimadzu UB10R-065U transducer
00841436107419Sterile endocavity needle guide with (3.5 x 20cm) latex covers (2) and (1.5 x 7cm) latex fingerc
00841436107389Sterile endocavity needle guide for use with Siemens BP9-4 transducers
00841436107372Sterile endocavity needle guide for use with Siemens EC9-4w and MC9-4 transducers
00841436107358Sterile endocavity needle guide for use with Siemens EV-8C4 transducers
00841436107334Sterile endocavity needle guide for use with Siemens BP9-4 transducers
00841436107327Sterile endocavity needle guide with (2.6 x 20cm) and (3.5 x 20cm) latex covers for use with Sie
00841436107310Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with Sieme
00841436107297Sterile endocavity needle guide for use with Siemens EC9-4 and EV9-4 (on G40, Acuson X150, X300)
00841436107259Sterile endocavity needle guide for use with Siemens BE9-4 transducers
00841436107242Sterile endocavity needle guide with (2 x 20cm) and (3.5 x 20cm) latex covers for use with Sieme
00841436107136Disposable sterile endocavity needle guide for use with SonoSite
00841436109949Disposable sterile endocavity needle guide with (3.5 x 20cm) latex covers (2) for use with SonoS
00841436106948Sterile endocavity needle guide for use with SonoSite
00841436106788Sterile endocavity needle guide with (2.0 x 20cm) and (3.5 x 20cm) latex covers for use with Ph
00841436106771Sterile endocavity needle guide for use with Philips C10-4ec transducers
00841436106689Sterile quick-release endocavity needle guide with 10-11GA, 14GA, 16-18GA inserts, (2.0 x 20cm)
00841436106672Sterile quick-release endocavity needle guide with 10-11GA, 14GA, 16-18GA inserts for use with P

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