FDA.reportPublic FDA data

CASPAR DRILL GUIDE

Primary DI
00192896037274
Brand
CASPAR DRILL GUIDE
Company
SONTEC INSTRUMENTS, INC.
Model
416-342
Catalog number
416-342
Device description
CASPAR DRILL GUIDE LEFT
Published
2018-09-18
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
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
00192896037274PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896037274001928960372741928960372740192896037274

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical instrument handle quick lock adaptorA connecting device designed to allow the attachment of an ophthalmic surgical instrument tip to an ophthalmic surgical instrument handle. It is typically in the form of a small, stainless steel, circular adaptor with a threaded interface that attaches to a threaded portion of the handle and provides a quick lock mechanism (e.g., bayonet fitting) that secures/releases the inserted tip. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Moist Heat or Steam 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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00192896025929MEYERDING RETRACTOR207-411207-4112018-09-12
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00192896099753LUXATOR ELEVATOR1100-586S11100-586S12018-09-21
00192896015272ENUCLEATION SCISSORS13-980513-98052018-09-13
00192896015289ENUCLEATION SCISSORS13-981013-98102018-09-13
00192896015296ENUCLEATION SCISSORS13-982013-98202018-09-13
00192896017214CASTROVIEJO LIP GRAFT CLAMP FORCEPS14-972514-97252018-09-17
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