FDA.report

GEN2

Primary DI
00840343718282
Brand
GEN2
Company
SURGIX MEDICAL LLC
Model
G2OB1576
Catalog number
G2OB1576
Device description
THOMAS UTERINE SOUND, MALLEABLE, GRADUATED IN CM, SILVER PLATED, 12-1/2" (32CM)
Published
2023-08-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HHMSound, Uterine

Product Code Classifications

CodeDeviceSpecialtyClass
HHMSound, UterineObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840343718282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343718282008403437182828403437182820840343718282

GMDN Terms

TermDefinition
Uterine sound, reusableA 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 reusable device intended to be sterilized prior to use.

Device Sizes

TypeValueUnit
Length12.5Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags

DUNS number
080402644
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840343727178GEN2G2N99727G2N997272025-12-11
00840343726898GEN2G2NHX28085G2NHX280852025-09-11
00840343726904GEN2G2NHX29085G2NHX290852025-09-11
00840343726911GEN2G2NHX29045G2NHX290452025-09-11
00840343726928GEN2G2NHX29055G2NHX290552025-09-11
00840343726935GEN2G2NHX29065G2NHX290652025-09-11
00840343726942GEN2G2G21340G2G213402025-09-11
00840343726621GEN2G2N11074G2N110742025-08-05
00840343726645GEN233501-41-00033501-41-0002025-08-05
00840343726652GEN2G2G36083 G2G36083 2025-08-05
00840343726669GEN2G2N81430G2N81430 2025-08-05
00840343726676GEN2G2N81420G2N81420 2025-08-05
00840343726683GEN2G2N81431G2N814312025-08-05
00840343726690GEN2G2N81421G2N814212025-08-05
00840343726706GEN2G2N81433G2N814332025-08-05
00840343726713GEN2G2N81423G2N814232025-08-05
00840343726584GEN2G2G12090G2G120902025-07-09
00840343726591GEN2G2N48721TCG2N48721TC2025-07-09
00840343726607GEN2G2N99514G2N995142025-07-09
00840343726614GEN2G2N99515G2N995152025-07-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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
05010058179585InstrapacROBINSON HEALTHCARE LIMITEDHHM2025-05-21
04049047064725GimmiGimmi GmbHHHM2025-05-20
04049047064923GimmiGimmi GmbHHHM2025-05-20
04049047045267GimmiGimmi GmbHHHM2025-05-14
04049047045328GimmiGimmi GmbHHHM2025-05-14
00190776394882MillenniumAvalign Technologies, Inc.HHM2025-05-08
00190776393175MillenniumAvalign Technologies, Inc.HHM2025-05-05
00194613033750MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613082673MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613087029MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00194613099855MSI Precision Specialty InstrumentsMed Saver, Inc.HHM2025-03-21
00190776388270MillenniumAvalign Technologies, Inc.HHM2024-11-13
05060212057563Sims Uterine SoundDTR MEDICAL LIMITEDHHM2024-10-14
10841742149124HNM MEDICALHNM STAINLESS, LLC.HHM2024-08-30
00190776384906MillenniumAvalign Technologies, Inc.HHM2024-08-26
00840343722890GEN2SURGIX MEDICAL LLCHHM2024-06-28
00840183525828BR Surgical, LLCBR Surgical, LLCHHM2024-06-04
00810123207183Adler Instrument CompanyAdler, Inc.HHM2024-05-10
04719894432854Bioteque Taiwan Ltd.Bioteque Taiwan Ltd.HHM2024-04-08
00840343721978GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840343721985GEN2SURGIX MEDICAL LLCHHM2024-04-05
00840183507121BR Surgical, LLCBR Surgical, LLCHHM2024-03-15
00840183506322BR Surgical, LLCBR Surgical, LLCHHM2024-03-13
00840183506384BR Surgical, LLCBR Surgical, LLCHHM2024-01-30
GYNX43340GynexGYNEX CORPORATIONHHM2023-12-19