FDA.reportPublic FDA data

HEARTLINE JAMESON TENOTOMY SCISSORS

Primary DI
00192896010901
Brand
HEARTLINE JAMESON TENOTOMY SCISSORS
Company
SONTEC INSTRUMENTS, INC.
Model
2800-7831S
Device description
HEARTLINE JAMESON TENOTOMY SCISSORS CURVED BLADE SQUEEZE HANDLE
Published
2018-08-24
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152400000General & Plastic Surgery InstrumentsSontec Instruments, Inc.2016-01-22GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B09928007831S0PreviousHIBCC0
00192896010901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896010901001928960109011928960109010192896010901

GMDN Terms#

Term, Definition table
TermDefinition
Vascular scissorsA hand-held, manual surgical instrument designed to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. Often referred to as micro-scissors, it is a metallic device with two small pivoted blades which cut with a shearing action. The blades are often pointed to penetrate the vessel wall, may be straight, curved sideways, or acutely angled, and may include carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length19.1Centimeter

Sterilization Methods#

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

Contacts#

Phone, Email table
PhoneEmail
800-821-7496info@sontecinstruments.com

Regulatory Flags#

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

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00192896123786Prince Trachoma Eye Forceps14-968014-96802026-09-18
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00192896123656Ferguson Abdominal Scissors110-287110-2872026-08-27
00192896123663Meyerding Finger Retractor205-856Q205-856Q2026-08-27
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00192896123571Adson Needle Holding Forceps140-300140-3002026-07-27
00192896123557Debakey Neonatal Clamp2100-580B2100-580B2026-07-10
00192896078819FERRIS-SMITH KERRISON404-682404-6822018-09-20
00192896117129Meeker Hemostatic Forceps2200-440Q2200-440Q2024-03-25
00192896123502Stefan Bone Holding Forceps1103-011Q1103-011Q2026-06-24
00192896123519Rochester Carmalt Forceps1100-150L1100-150L2026-06-24
00192896123526Rochester Carmalt Forceps1100-150LQ1100-150LQ2026-06-24

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