FDA.reportPublic FDA data

SONTEC KEYLESS I.M. PIN CHUCK SET

Primary DI
00192896081703
Brand
SONTEC KEYLESS I.M. PIN CHUCK SET
Company
SONTEC INSTRUMENTS, INC.
Model
1103-194T-SET
Catalog number
1103-194T-SET
Device description
SONTEC KEYLESS I.M. PIN CHUCK SET WITH LOCK SYSTEM 3/8 INCH STAINLESS STEEL INCLUDING T-SHAPED HANDLE
Published
2018-09-21
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
EMJELEVATOR, SURGICAL, DENTAL
HTWBit, Drill
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1
HTWBit, DrillOrthopedic1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896081703PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896081703001928960817031928960817030192896081703

GMDN Terms#

Term, Definition table
TermDefinition
External orthopaedic fixation system, reusableAn assembly of devices designed to stabilize fractured bones, other than those in the vertebral column, to promote treatment and healing. It typically consists of an external plastic and/or metallic fixator (a framework) and other external and/or implantable components such as clamps, rods, rings, cams, bushings, collars, bolts and nuts; it may also include some instrumentation (e.g., screw drivers, wrenches, drills). It is used mainly to help the healing of long bones such as the femur, tibia and humerus, as well as fractures of the wrist, elbow, knee, hip and ankle, joint fusions, and limb lengthening. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length0.375Inch

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

Regulatory Flags#

DUNS number
040729840
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
00192896012639ALGERBRUSH DIAMOND BURR11-461011-46102018-09-18
00192896012646ALGERBRUSH DIAMOND FINE GRIT BURR11-461111-46112018-09-18
00192896012653ALGERBRUSH DIAMOND BURR11-461211-46122018-09-18
00192896012660ALGERBRUSH DIAMOND BURR11-461311-46132018-09-18
00192896012677ALGERBRUSH DIAMOND BURR11-461411-46142018-09-18
00192896072398ALGERBRUSH DIAMOND BURR11-460911-46092018-09-19
00192896092792UNIVERSITY OF MINNESOTA CHEEK RETRACTOR207-210207-2102019-01-03
00192896044661BARR PROBE508-547508-5472018-09-14
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00192896123403Mictec High Frequency Cable26944-3226944-322026-05-11
00192896123410Biopsy Cup2901-125L2901-125L2026-05-11
00192896112193HU Capsular Polisher12-268512-26852022-02-03
00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
00192896025936MEYERDING RETRACTOR207-413207-4132018-09-12
00192896025943MEYERDING RETRACTOR207-415207-4152018-09-12
00192896100671TEALES GORGET SPECULUM516-506516-5062025-02-24
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00192896115750Teales Gorget SpeculumT516-507T516-5072023-11-03

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