FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331158698
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
NSFE582K
Catalog number
NSFE582K
Device description
"YASARGIL Clip Applier, bayonet handle, straight jaw, standard, 8"""
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
HBTApplier, Hemostatic Clip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBTApplier, Hemostatic ClipGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331158698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331158698008423311586988423311586980842331158698

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument clipA device designed to hold surgical instruments together; typically those with ring handles. This can be for sterilization, storage purposes, and/or to keep surgical instruments used for a particular procedure together prior to being lain out for surgery. It is typically designed like a very large safety pin (i.e., an elongated spring wire clasp with a locking catch onto which the instruments are threaded, usually by the ring handle). It is typically made of stainless steel or chromed metal. 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
03661522100882Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100899Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100905Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100929Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100936Applier, hemostatic clipPETERS SURGICALHBT2024-01-02
03661522100912Applier, hemostatic clipPETERS SURGICALHBT2023-12-28
03661522039540Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039557Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039564Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039571Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039588Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039595Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039601Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039649Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039656Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039663Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039670Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039687Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039694Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039700Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039717Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039724Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039731Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039748Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039755Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039762Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039786Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039793Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039809Applier, hemostatic clipPETERS SURGICALHBT2023-06-08
03661522039816Applier, hemostatic clipPETERS SURGICALHBT2023-06-08