US-01-025

GUDID 10852073002408

C R I

Uterine sound, single-use
Primary Device ID10852073002408
NIH Device Record Key0337cf3b-bff7-4d9c-918a-27b74dc98938
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberUterine Sound
Catalog NumberUS-01-025
Company DUNS130814890
Company NameC R I
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-556-0349
Emailsales@thomasmedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852073002401 [Primary]
GS110852073002408 [Package]
Contains: 00852073002401
Package: Box [25 Units]
In Commercial Distribution

FDA Product Code

HHMSound, Uterine

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-10-11

Devices Manufactured by C R I

10852073002361 - NA2020-07-02 Round Loop, Loop Size: 20mm x 13mm
10852073002378 - NA2020-07-02 Round Loop, Loop Size: 20mm x 15mm
10852073002316 - NA2020-06-29 Round Loop, Loop Size: 15mm x 15mm
10852073002484 - NA2020-06-29 Round Loop, Loop Size: 15mm x 10mm
00852073002814 - NA2020-01-21 Balloon catheter with an insertion sheath for hysterosalpingography and sonohysterography for use with saline or water-based con
10852073002231 - NA2019-05-27 Square Loop, Loop Size: 10mm x 4mm
10852073002248 - NA2019-05-27 Round Loop, Loop Size: 5mm x 5mm
10852073002255 - NA2019-05-27 Round Loop, Loop Size: 10mm x 5mm

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