FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331132742
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6351-12
Catalog number
OB6351-12
Device description
"sims uterine sound, malleable, silver plated, 13"" (33.0 cm), graduated in cm"
Published
2022-11-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
00842331132742PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331132742008423311327428423311327420842331132742

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1877-860-6686info@novosurgical.com

Regulatory Flags#

DUNS number
033029433
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G586N6863510Novo SurgicalN6863-51N6863-512023-12-18
G586N6863530Novo SurgicalN6863-53N6863-532023-12-18
G586N6863540Novo SurgicalN6863-54N6863-542023-12-18
G586N6863550Novo SurgicalN6863-55N6863-552023-12-18
G586N6863580Novo SurgicalN6863-58N6863-582023-12-18
G586N6863590Novo SurgicalN6863-59N6863-592023-12-18
G586N98831250Novo SurgicalN98831-25N98831-252023-12-18
00842331174377Novo Surgical Inc. N3807-12N3807-122022-11-14
00842331153556Novo Surgical Inc. N6863-52N6863-522022-11-12
00842331165771Novo Surgical Inc. N6863-56N6863-562022-11-13
00842331169717Novo Surgical Inc. N6863-57N6863-572022-11-13
00842331170836Novo Surgical Inc. N3807-13N3807-132022-11-13
00842331194023Novo Surgical Inc. OP7195-242023-12-07
G586NS41500200Novo SurgicalNS4150020NS41500202025-09-15
G586NS41500250NovosurgicalNS4150025NS41500252025-09-15
G586NS720151200Novo SurgicalNS720-1512-02025-09-15
G586NS720155800Novo Surgical IncNS720-1558-0NS720-1558-02025-09-15
00842331192968Novo Surgical IncG1911-38IG-NS2023-08-21
G586NS80292210Novo SurgicalNS80-2922-1NS80-2922-12025-05-19
G586N8810500Novo SurgicalN8810-502025-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04049047110170GimmiGimmi GmbHHHM2025-05-27
04049047110187GimmiGimmi GmbHHHM2025-05-27
04049047110194GimmiGimmi GmbHHHM2025-05-27
04049047110200GimmiGimmi GmbHHHM2025-05-27