FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331155468
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
UR6105-54
Catalog number
UR6105-54
Device description
"pratt fistula probe, crypt hooks, 8 1/4"" (21.0 cm), long hook"
Published
2022-11-12
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
EXXProbe, Rectal, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXXProbe, Rectal, Non-PoweredGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331155468PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331155468008423311554688423311554680842331155468

GMDN Terms#

Term, Definition table
TermDefinition
Rectal probeA hand-held manual surgical instrument designed for exploring the tissues and structures of the rectum during a gastroenterological/urological surgical procedure. 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
00194613026622MSI Precision Specialty InstrumentsMed Saver, Inc.EXX2025-08-01
04049047024408GimmiGimmi GmbHEXX2025-04-16
04049047024477GimmiGimmi GmbHEXX2025-04-16
00840306830778Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-19
00840306830341Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830358Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840306830365Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-07-12
00840183526962BR Surgical, LLCBR Surgical, LLCEXX2024-05-29
00840306826832Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-05-10
00840306824166Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-29
00840306821684Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306821691Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-04-08
00840306806728Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
00840306807336Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2024-02-23
G586UR96105210Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR96105610Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-19
G586UR6105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105520Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105530Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
G586UR96105540Novo SurgicalNOVO SURGICAL, INC.EXX2023-12-18
00860001161618GreenEggEndoglow, LLCEXX2023-07-07
00840306808258Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00840306808326Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.EXX2022-11-14
00842331181887Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331185564Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-14
00842331152450Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-12
00842331131493Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331133619Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331135583Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10
00842331136306Novo Surgical Inc. NOVO SURGICAL, INC.EXX2022-11-10