FDA.reportPublic FDA data

Novo Surgical

Primary DI
G586OB96364610
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
OB96364-61
Catalog number
OB96364-61
Device description
"zenith rogers-type hysterectomy forceps, 2x3 atraumatic teeth, sarot-style shanks, 1-1/2"" (38.0 mm) jaw length, straight, 8-3/4"" (22.0 cm)"
Published
2023-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HGCCLAMP, UTERINE

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G586OB96364610PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. 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
+1(877)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
00190776410698MillenniumAvalign Technologies, Inc.HGC2025-09-12
00190776405311MillenniumAvalign Technologies, Inc.HGC2025-07-15
00190776399818MillenniumAvalign Technologies, Inc.HGC2025-06-02
G586OB2791320Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB2792320Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300700Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300710Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300720Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300730Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300740Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300750Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300760Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300770Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300780Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300790Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300820Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300830Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300860Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300910Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300920Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300930Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300940Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6300950Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6356310Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6356860Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6356870Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6358670Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6358680Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6359130Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18
G586OB6359140Novo SurgicalNOVO SURGICAL, INC.HGC2023-12-18