FDA.reportPublic FDA data

INDIA SHARPENING STONE

Primary DI
00192896048157
Brand
INDIA SHARPENING STONE
Company
SONTEC INSTRUMENTS, INC.
Model
1100-579
Catalog number
1100-579
Device description
INDIA SHARPENING STONE MEDIUM 105-115mm X 40-45mm X 10/3mm SS5
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMIFile, Bone, Surgical
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMIFile, Bone, SurgicalDental1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896048157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896048157001928960481571928960481570192896048157

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin sharpenerA hand-held manual surgical instrument used to alter the tip of a bioabsorbable bone pin, e.g., to shorten it, prior to insertion into the patient. It is typically designed with a handle at the proximal end and a long, sturdy, shaft that terminates in a sharpener with a cutting blade similar in design to a pencil sharpener. It is typically made of high-grade stainless steel and/or synthetic material and is used by the surgeon or assistive surgical staff inside the sterile field of the operating room (OR). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height0.375Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Dry Heat Sterilization""]"
Moist Heat or Steam Sterilization;Dry Heat Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800) 821-7496info@sontecinstruments.com
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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