FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331134531
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
UR6286-21
Catalog number
UR6286-21
Device description
"guyon (van buren) catheter stylet, 4 fr., straight, 15 3/4"" (40.0 cm)"
Published
2022-11-10
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
EYAStylet, Ureteral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EYAStylet, UreteralGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331134531PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331134531008423311345318423311345310842331134531

GMDN Terms#

Term, Definition table
TermDefinition
Peritoneal catheter styletA thin wire/rod intended to be inserted within the lumen of a peritoneal catheter (e.g., peritoneal dialysis catheter, peritoneal drainage catheter, peritoneal lavage catheter, abdominal fluid shunt system peritoneal catheter) to stiffen/maintain the shape of the catheter to assist introduction; it may also be intended to assist insertion of a bladder catheter used for drainage of fluid from the peritoneal cavity to the bladder. It is intended to be removed once the catheter is in place. This is a single-use 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
00821925003446GYRUS ACMI, INCGyrus ACMI, LLCEYA2024-07-24
G586UR96286210Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
G586UR96286410Novo SurgicalNOVO SURGICAL, INC.EYA2023-12-18
00842962125588HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125595HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125601HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125618HNM MEDICALHNM STAINLESS, LLC.EYA2023-04-03
00842962125625HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125632HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125649HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125656HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125670HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125687HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125694HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125700HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125717HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125724HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125731HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125748HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125755HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125762HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125809HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125816HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842962125823HNM MEDICALHNM STAINLESS, LLC.EYA2023-03-29
00842331135897Novo Surgical Inc. NOVO SURGICAL, INC.EYA2022-11-10
00816349011733ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011740ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011757ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011764ZIPwire™Lake Region MedicalEYA2020-06-30
00816349011788ZIPwire™Lake Region MedicalEYA2020-06-30