FDA.reportPublic FDA data

Novo Surgical Inc.

Primary DI
00842331131219
Brand
Novo Surgical Inc.
Company
NOVO SURGICAL, INC.
Model
NS5837
Catalog number
NS5837
Device description
"root elevators winter 14 l, 5"""
Published
2022-11-10
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
EMJElevator, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842331131219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842331131219008423311312198423311312190842331131219

GMDN Terms#

Term, Definition table
TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. 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
00810189451216Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451223Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451230Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451247Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451254Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451261Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451278Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451285Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451292Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451308Surgical DesignSurgical Design, Inc.EMJ2026-06-06
00810189451315Surgical DesignSurgical Design, Inc.EMJ2026-06-06
G149TBSB7540TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7550TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7560TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7570TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7580TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7590TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7600TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7610TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7620TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7630TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7640TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7650TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7660TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7670TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7680TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7690TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7700TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7710TBS BASICSACME ENTERPRISE.EMJ2026-05-21
G149TBSB7830TBS BASICSACME ENTERPRISE.EMJ2026-05-21