FDA.reportPublic FDA data

NA

Primary DI
10852073002415
Brand
NA
Company
C R I
Model
Uterine Sound, Printed
Catalog number
US-01-025P
Device description
With Tip Markings
Published
2016-10-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HHMSound, Uterine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10852073002415PackageGS150In Commercial Distribution
00852073002418PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085207300241510852073002415
00852073002418008520730024188520730024180852073002418

GMDN Terms#

Term, Definition table
TermDefinition
Uterine sound, single-useA sterile, hand-held manual instrument designed to measure and/or explore the internal depth or length of the uterus, cervix, and/or vagina. It is a slender hollow or solid cylindrical instrument made of metal or plastic typically with graduations of length displayed along its working end. It is typically available in a range of sizes and flexibilities. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(800) 556-0349Sales@ThomasMedical.com

Regulatory Flags#

DUNS number
130814890
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852073002258NALoop ElectrodeLE-04-1052016-10-07
00852073002272NALoop ElectrodeLE-05-1032016-10-07
00852073002289NALoop ElectrodeLE-06-1012016-10-10
00852073002296NALoop ElectrodeLE-06-1082016-10-10
00852073002302NALoop ElectrodeLE-07-1582016-10-07
00852073002333NALoop ElectrodeLE-09-2082016-10-10
00852073002388NALoop ElectrodeLE-12-2512016-10-10
00852073002395NABall ElectrodeLE-13-0032016-10-10
00852073002432NABall ElectrodeLE-14-0052016-10-10
00852073002463NALoop ElectrodeLE-24-2012016-10-10
00852073002364NALoop ElectrodeLE-10-2032016-10-10
00852073002371NALoop ElectrodeLE-11-2052016-10-10
10852073002361NALoop ElectrodeLE-10-2032016-10-10
10852073002378NALoop ElectrodeLE-11-2052016-10-10
00852073002319NALoop ElectrodeLE-08-1512016-10-07
00852073002487NALoop ElectrodeLE-26-1502016-10-10
10852073002316NALoop ElectrodeLE-08-1512016-10-07
10852073002484NALoop ElectrodeLE-26-1502016-10-10
00852073002814NATwo-Tap HS Catheter, 5FTMI11812016-09-30
00852073002234NALoop ElectrodeLE-01-1042016-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405892MillenniumAvalign Technologies, Inc.HHM2026-07-26
00860011927617Monarch Medical ProductsBioteque Taiwan Ltd.HHM2026-07-24
04719894436524LTL MedicalBioteque Taiwan Ltd.HHM2026-07-24
00190776421618MillenniumAvalign Technologies, Inc.HHM2026-06-23
00190776408442MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419295MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419301MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419318MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419325MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419332MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419356MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419363MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776419370MillenniumAvalign Technologies, Inc.HHM2026-04-14
00190776413361MillenniumAvalign Technologies, Inc.HHM2025-10-09
00194613017545MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613085841MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00194613111083MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-08-01
00190776405670MillenniumAvalign Technologies, Inc.HHM2025-07-18
00190776405687MillenniumAvalign Technologies, Inc.HHM2025-07-18
04049047110064GimmiGimmi GmbHHHM2025-05-27
04049047110071GimmiGimmi GmbHHHM2025-05-27
04049047110088GimmiGimmi GmbHHHM2025-05-27
04049047110095GimmiGimmi GmbHHHM2025-05-27
04049047110101GimmiGimmi GmbHHHM2025-05-27
04049047110118GimmiGimmi GmbHHHM2025-05-27
04049047110125GimmiGimmi GmbHHHM2025-05-27
04049047110132GimmiGimmi GmbHHHM2025-05-27
04049047110149GimmiGimmi GmbHHHM2025-05-27
04049047110156GimmiGimmi GmbHHHM2025-05-27
04049047110163GimmiGimmi GmbHHHM2025-05-27