FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586OB631721NCDT0
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
OB6317-21NCDT
Catalog number
OB6317-21NCDT
Device description
graves nonconductive speculum, one disposable smoke tube, medium, 10.0 cm x 4.0 cm blades
Published
2024-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HDFSpeculum, Vaginal, Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586OB631721NCDT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00190776428150MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428181MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428198MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776428242MillenniumAvalign Technologies, Inc.HDF2026-08-27
00190776419622MillenniumAvalign Technologies, Inc.HDF2026-08-23
B382SD915039080Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039140Surgical DirectSurgical Direct, Inc.HDF2026-08-21
B382SD915039150Surgical DirectSurgical Direct, Inc.HDF2026-08-21
00190776426439MillenniumAvalign Technologies, Inc.HDF2026-08-18
00190776426446MillenniumAvalign Technologies, Inc.HDF2026-08-18
00198506093944ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094088ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094095ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094101ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00198506094118ELMED INCORPORATEDELMED INCORPORATEDHDF2026-08-18
00850088713534PRINCETONPrinceton Medical Group, Inc.HDF2026-08-14
00190776408817MillenniumAvalign Technologies, Inc.HDF2026-08-03
00190776422639MillenniumAvalign Technologies, Inc.HDF2026-08-03
00198506093845ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-29
00198506093852ELMEDELMED INCORPORATEDHDF2026-07-29
00198506093142ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093265ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093272ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
00198506093418ELMED INCORPORATEDELMED INCORPORATEDHDF2026-07-28
B382SD915038100Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915038120Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD915039110Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471000Surgical DirectSurgical Direct, Inc.HDF2026-07-28
B382SD9150471130Surgical DirectSurgical Direct, Inc.HDF2026-07-28