FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331181092
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
N6871-33
Catalog number
N6871-33
Device description
"hudson burr, 7/8"" (22.0 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
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331181092PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331181092008423311810928423311810920842331181092

GMDN Terms#

Term, Definition table
TermDefinition
Biopsy drill bitA shaft of metal designed to excise (cut out) a small section of bone or cartilage for microscopic examination. It is mounted into a surgical drilling device, either manual or powered, and when rotated at an appropriate speed will perform the required operation. 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
09120125220273Shark Screw® drillsurgebright GmbHHTW2026-04-30
08053782783724BRM TOOL VIP SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2026-04-29
08059386744260Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386744277Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-06
08059386742327Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742341Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742358Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742365Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742372Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742389Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742396Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386742402Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-11-05
08059386747957Orthopaedic Surgical InstrumentsCITIEFFE SRLHTW2025-10-27
08053782780464BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
08053782780471BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLHTW2025-10-15
G79151202112817G0WishFIXRed Star Contract Manufacturing Inc.HTW2025-10-06
09120125220044Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220051Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220068Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220075Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220082Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220099Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220105Shark Screw® drillsurgebright GmbHHTW2025-09-16
09120125220112Shark Screw® drillsurgebright GmbHHTW2025-09-16
08809416065601Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065618Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416065625Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066905Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416066912Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24
08809416068671Surgical InstrumentOSTEONIC CO.,Ltd.HTW2025-06-24