FDA.reportPublic FDA data

Novo Surgical

Primary DI
00842331126352
Brand
Novo Surgical
Company
NOVO SURGICAL, INC.
Model
C6581-17
Device description
nelson (patterson) trocar, for intercostal drainage, 7.5 mm, medium (26 fr.)
Published
2020-01-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
DRCTrocar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DRCTrocarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331126352PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331126352008423311263528423311263520842331126352

GMDN Terms#

Term, Definition table
TermDefinition
ENT trocar bladeA rigid, surgical instrument with a sharp pyramidal or conical point used to puncture body cavities during ear/nose/throat (ENT) surgery. It can be assembled and used together with a compatible cannula (not included) filling its lumen, thereby allowing the introduction of this assembly; following puncture, the trocar blade is withdrawn. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
G586N8810500Novo SurgicalN8810-502025-05-19
G586NS38796080NOVOSURGICALNS38-796-08NS38-796-082025-05-02
G586NS50468110Novo SurgicalNS50-4681-1NS50-4681-12025-05-02
G586G171631E0NovosurgicalG1716-31E2025-04-17
G586G311041NC0Novo SurgicalG3110-41NC2025-03-21
G586N697205A0NovosurgicalN6972-05AN6972-05A2025-02-06
G586N697206A0NovosurgicalN6972-06AN6972-05A2025-02-06
G586NS02533010Novo SurgicalNS02-5330-1NS02-5330-12025-02-06
G586NS5230002SPFB10Novo SurgicalNS52-300-02SPFB-1NS02-5330-12025-02-06
G5862562529S0Novosurgical25625-29S2025-01-02
G586N6969090NovosurgicalN6969-092025-01-02
G586N6971710NovosurgicalN6971-712025-01-02
G586N6971730NovosurgicalN6971-732025-01-02
G586N6972700NovosurgicalN6972-702025-01-02
G586NS47110610NovosurgicalNS47-1106-12025-01-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867500914Arthrex®ARTHREX, INC.DRC2026-03-13
04262494463594N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463631N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463785N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463792N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463808N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463815N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463822N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463839N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494463846N/ADoppkon GmbH & Co. KGDRC2025-09-12
04262494461064N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461224N/ADoppkon GmbH & Co. KGDRC2025-08-05
04262494461019N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461026N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461033N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461040N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461057N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461071N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461088N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461095N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461101N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461118N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461125N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461132N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461149N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461156N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461163N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461170N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461187N/ADoppkon GmbH & Co. KGDRC2025-08-04
04262494461194N/ADoppkon GmbH & Co. KGDRC2025-08-04