FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331181917
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
UR6191-46
Catalog number
UR6191-46
Device description
"yeoman rectal biopsy forceps, 4.0 mm x 11.0 mm bite, oval basket, 13 3/4"" (35.0 cm) shaft"
Published
2022-11-14
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
FCLForceps, Biopsy, Non-Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FCLForceps, Biopsy, Non-ElectricGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331181917PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331181917008423311819178423311819170842331181917

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
08809909421723Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421730Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421747Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421754Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421761Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421778Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421785Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421792Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421808Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421815Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421822Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421839Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421846Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421853Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421860Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421877Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421884Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421891Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421907Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421914Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421921Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421938Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421945Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421952Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421969Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421976Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421983Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08809909421990Biopsy ForcepsTAEWOONGMEDICAL.CO.,LTDFCL2026-04-27
08051887049837THD BIOPSYTHD SPAFCL2026-01-07
08051887049851THD BIOPSYTHD SPAFCL2026-01-07