FDA.reportPublic FDA data

EOS

Primary DI
04712568360286
Brand
EOS
Company
NORTH EOS INDUSTRIES INC.
Model
EosSounds
Device description
EOS DISPOSABLE UTERINE SOUNDS
Published
2018-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
04712568360286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04712568360286047125683602864712568360286

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

Regulatory Flags#

DUNS number
656812989
Device count
1
Premarket exempt
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04712568360873EOSEosProbe2018-11-30
04712568360514EOSEosCurette-RING BLUE2018-08-10
04712568360521EOSEosCurette- SPOON GREEN2018-08-10
04712568360361EOSEosSuction2018-08-10
04712568360385EOSEyelidSpec2018-08-10
04712568360538EOSEosOtoSpec I - 4.5MM (Keeler)2018-08-15
04712568360545EOSEosOtoSpec I-3.5MM (Keeler)2018-08-15
04712568360552EOSEosOtoSpec I -2.5MM (Keeler)2018-08-15
04712568360569EOSEosOtoSpec I -5.5mm (Keeler)2018-08-15
04712568360583EOSEosOtoSpec II -4.25MM (WA)2018-08-15
04712568360590EOSEosOtoSpec II -2.75MM (WA)2018-08-15
04712568360781EOSEosOtoSpec III-2.5MM, LARGER(HEINE)2018-08-15
04712568360798EOSEosOtoSpec III-4.0MM,LARGER (HEINE)2018-08-15
04712568360804EOSEosOtoSpec III -(LOCK)2.5MM SMALLER (HEINE)2018-08-15
04712568360811EOSEosOtoSpec III (LOCK)-4.0MM SMALLER (HEINE)2018-08-15
04712568360828EOSEosOtoSpec IV- Veterinary 4MM2018-08-15
04712568360835EOSEosOtoSpec IV-Veterinary 6MM (HEINE)2018-08-15
04712568360842EOSEosOtoSpec IV-Veterinary 9MM (HEINE)2018-08-15
04712568360859EOSEosOtoSpec IV-GUTTER-VET. 4MM(HEINE)2018-08-15
04712568360866EOSEosOtoSpec IV-GUTTER-VET. 6MM(HEINE)2018-08-15

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