FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331183904
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
UR6217-17
Catalog number
UR6217-17
Device description
"bakes common duct dilator, 11 3/4"" (30.0 cm), 6.0 mm"
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
FFPDilator, Rectal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFPDilator, RectalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331183904PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331183904008423311839048423311839040842331183904

GMDN Terms#

Term, Definition table
TermDefinition
Common bile duct dilatorA hand-held manual surgical instrument designed to dilate the common bile duct, i.e., the union of the cystic and hepatic ducts. It typically consists of a slender hollow or solid body instrument made of metal or plastic in a cylindrical form. It is available in a variety of sizes (diameters) and flexibilities. 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
00850005838449Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838456Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838463Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838487Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838494Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838500Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838517Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838524Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838531Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838548Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
00850005838555Intimate RosePLUS EV HOLDINGS INC.FFP2024-12-10
G586UR6213360Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR6214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
G586UR96214140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-19
00842331194603Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216100Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6216160Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217120Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217130Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217140Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217150Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217210Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217220Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217230Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
G586UR6217240Novo SurgicalNOVO SURGICAL, INC.FFP2023-12-18
08033638801147DilastomSAPI MED SPAFFP2023-08-02
08033638803929DilastomSAPI MED SPAFFP2023-08-02