FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331136467
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
OB6358-17
Catalog number
OB6358-17
Device description
jacobs vulsellum forceps, 2x2 teeth, 6.0 mm wide, 8 1/4" (21.0 cm), straight
Published
2022-11-10
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
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
00842331136467PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331136467008423311364678423311364670842331136467

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

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