FDA.reportPublic FDA data

NEONAIL

Primary DI
07899893220359
Brand
NEONAIL
Company
Neoortho Produtos Ortopédicos S/A.
Model
930.004
Device description
Jacob’s Mandril
Published
2023-11-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07899893220359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07899893220359078998932203597899893220359

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill chuckA device designed to grip a cutting tool (normally a drill bit or other rotational cutting tool) using three adjustable jaws that are geared to be manually closed concentrically upon the cutting tool. It is attached (locked) to a surgical drilling machine which is usually powered, but may be manual. A special key is often used to close and tighten the jaws. Commonly known as a Jacobs chuck, it is typically made of high-grade stainless steel to resist the corrosive effects of sterilization processes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+554135351000sac@neoortho.com.br

Regulatory Flags#

DUNS number
914644351
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07899893203253NEONAIL932.2002015-10-07
07899893203260NEONAIL932.2012015-10-07
07899893203277NEONAIL932.2022015-10-07
07899893203284NEONAIL932.2102015-10-07
07899893203291NEONAIL933.5002015-10-07
07899893203307NEONAIL934.9002015-10-07
07899893203314NEONAIL934.9012015-10-07
07899893203321NEONAIL934.9022015-10-07
07899893203338NEONAIL934.9032015-10-07
07899893203345NEONAIL934.9042015-10-07
07899893203352NEONAIL934.9052015-10-07
07899893203369NEONAIL934.9062015-10-07
07899893203376NEONAIL934.9072015-10-07
07898624867580NEOPLATE942.6002015-09-25
07898624867597NEOPLATE942.6012015-09-25
07898624867603NEOPLATE942.6022015-09-25
07898624867610NEOPLATE942.6032015-09-25
07898624867627NEOPLATE942.6042015-09-25
07898624867634NEOPLATE942.6052015-09-25
07898624867641NEOPLATE942.6062015-09-25

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