FDA.reportPublic FDA data

Short Plaque Retriever

Primary DI
00192896108462
Brand
Short Plaque Retriever
Company
SONTEC INSTRUMENTS, INC.
Model
2700-0-04
Device description
Short Plaque Retriever
Published
2021-04-27
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
GAISTRIPPER, VEIN, REUSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAIStripper, Vein, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896108462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896108462001928961084621928961084620192896108462

GMDN Terms#

Term, Definition table
TermDefinition
Endarterectomy loopA hand-held manual surgical instrument intended to be used to grip and excise atherosclerotic deposits (i.e., thickened atheromatous tunica intima) from the lumen of an artery (i.e., endarterectomy). It will typically consist of a slender handle onto which a piece of flexible wire that ends in a small loop is attached or be used together with an endarterectomy loop puller. It is typically inserted percutaneously under radiographic guidance. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length7.25Inch

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
No natural rubber latex
true
Sterilization required before use
true

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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
00192896081635LUXATOR ELEVATOR1100-586C11100-586C12018-09-21
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