FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331168956
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6364-17
Catalog number
OB6364-17
Device description
"heaney hysterectomy forceps, curved, double groove, 14"" (35.0 cm)"
Published
2022-11-13
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
HGCClamp, Uterine

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331168956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331168956008423311689568423311689560842331168956

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery biopsy forceps, reusableA hand-held manual surgical instrument designed to obtain soft-tissue biopsy specimens from an open surgical wound or from within/near a large natural orifice (e.g., vagina, rectum) for histopathological examination; it is not intended for endoscopic or catheterized access. It is a metallic forceps-like instrument with a distal mechanism designed to bite/punch the biopsy sample and hold it for extraction when the handles are squeezed together. It is not designed for cutting bone (i.e., not a rongeur). This is a reusable device.

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
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