FDA.report

NIXON KNIFE

Primary DI
00192896056992
Brand
NIXON KNIFE
Company
SONTEC INSTRUMENTS, INC.
Model
1271-139D
Catalog number
1271-139D
Device description
NIXON KNIFE STRAIGHT SERRATED BANANA BLADEEXTRAEXTRA LARGE ROUND HANDLE
Published
2018-09-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does n
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTSKNIFE, ORTHOPEDIC

Product Code Classifications

CodeDeviceSpecialtyClass
HTSKnife, OrthopedicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00192896056992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896056992001928960569921928960569920192896056992

GMDN Terms

TermDefinition
Orthopaedic osteotome blade, reusableA sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on both sides; it is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length9Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts

PhoneEmail
+1(800) 821-7496info@sontecinstruments.com

Regulatory Flags

DUNS number
040729840
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

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