FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331162947
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N3961-36
Catalog number
N3961-36
Device description
hibbs chisel, 9 1/2" (24.0 cm), straight, 1" (25.0 mm)
Published
2022-11-13
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDGChisel (Osteotome)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDGChisel (Osteotome)General, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331162947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331162947008423311629478423311629470842331162947

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
B382SD914459320Surgical DirectSurgical Direct, Inc.KDG2026-02-25
B382SD914031000Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914031010Surgical DirectSurgical Direct, Inc.KDG2026-02-20
B382SD914456290Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663010Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663020Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663030Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD9144663040Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD914591000Surgical DirectSurgical Direct, Inc.KDG2026-02-09
B382SD921648100Surgical DirectSurgical Direct, Inc.KDG2026-02-09
00810158218635PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218734PRINCETONPrinceton Medical Group, Inc.KDG2026-01-20
00810158218499PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
00810158218536PRINCETONPrinceton Medical Group, Inc.KDG2026-01-15
B382SD48820520Surgical DirectSurgical Direct, Inc.KDG2025-12-02
00810158218086PRINCETONPrinceton Medical Group, Inc.KDG2025-11-24
00810158217393PRINCETONPrinceton Medical Group, Inc.KDG2025-09-29
B382SD9219563010Surgical DirectSurgical Direct, Inc.KDG2025-09-22
B382SD936682100Surgical DirectSurgical Direct, Inc.KDG2025-09-18
B382SD9146891000Surgical DirectSurgical Direct, Inc.KDG2025-09-12
00810158216471PRINCETONPrinceton Medical Group, Inc.KDG2025-08-21
00810158215894PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216044PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216051PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216068PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216075PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
00810158216082PRINCETONPrinceton Medical Group, Inc.KDG2025-08-18
B382SD921381020Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646030Surgical DirectSurgical Direct, Inc.KDG2025-08-11
B382SD921646040Surgical DirectSurgical Direct, Inc.KDG2025-08-11