FDA.reportPublic FDA data

Novo Surgical Inc

Primary DI
00842331193378
Brand
Novo Surgical Inc
Company
NOVO SURGICAL, INC.
Model
NSBF1W-1
Device description
miller-colburn bone file, #1, 18.0 cm
Published
2023-09-22
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
HTPFile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTPFileOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331193378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331193378008423311933788423311933780842331193378

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manual, reusableA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
10810128463574Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
10810128463581Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2026-05-13
06974940306642endophixSuzhou Endophix Co., Ltd.HTP2025-12-12
10818674026618Rasp Down Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
10818674026625Rasp Up Bend 20°T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTP2025-08-13
04047844052501INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844067390INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844099742INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101117INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844101155INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
04047844126998INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-06-04
00840286841955Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853965Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286853972Consensus Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-22
00840286841009TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-21
00840286855990TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856003TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856010TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856027TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840286856034TaperSet Hip SystemShalby Advanced Technologies, Inc.HTP2025-05-20
00840124518742FuzeFix MiniFUSION ORTHOPEDICS, LLCHTP2025-05-13
04047844059852INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-09
04046826034801MediconMedicon eG. Chirurgiemechaniker-GenossenschaftHTP2025-05-07
04047844058442INSTRUMENTSIGNUS Medizintechnik GmbHHTP2025-05-05
04047844058558RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058565RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058572RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058589RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058596RABEASIGNUS Medizintechnik GmbHHTP2025-03-12
04047844058602RABEASIGNUS Medizintechnik GmbHHTP2025-03-12