FDA.reportPublic FDA data

SERREFINE BULLDOG CLAMP

Primary DI
00192896017399
Brand
SERREFINE BULLDOG CLAMP
Company
SONTEC INSTRUMENTS, INC.
Model
14-9940
Catalog number
14-9940
Device description
SERREFINE BULLDOG CLAMP CROSS ACTION CURVED TIP
Published
2018-09-13
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
DXCClamp, Vascular
GDJClamp, Surgical, General & Plastic Surgery
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
HNRForceps, OphthalmicOphthalmic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123077000VASCULAR CLAMPSHebumedical GmbH2013-05-14DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896017399PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896017399001928960173991928960173990192896017399

GMDN Terms#

Term, Definition table
TermDefinition
Surgical bulldog clamp, reusableA hand-held manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping however it is not dedicated to a specific anatomy/surgery. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.5Inch

Sterilization Methods#

Method table
Method
"[""Dry Heat Sterilization"", ""Moist Heat or Steam Sterilization""]"
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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00192896123564Castroviejo Corneal Scissors13-2540F13-2540F2026-07-27
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
00192896123533Rochester Carmalt Forceps1100-152LQ1100-152LQ2026-06-24
00192896123540Green Retractor207-298207-2982026-06-24
00192896103603ROCHESTER CARMALT FORCEPS1100-151Q1100-151Q2020-07-23
00192896038110SONTEC-MICHELE TREPHINE419-392419-3922018-09-11
00192896038127SONTEC-MICHELE TREPHINE419-393419-3932018-09-11
00192896038134SONTEC-MICHELE TREPHINE419-394419-3942018-09-11
00192896038141SONTEC-MICHELE TREPHINE419-395419-3952018-09-11
00192896038158SONTEC-MICHELE TREPHINE419-396419-3962018-09-11
00192896038165SONTEC-MICHELE TREPHINE419-397419-3972018-09-11
00192896038172SONTEC-MICHELE TREPHINE419-398419-3982018-09-11
00192896094710INGE LAMINA SPREADER RETRACTOR417-056417-0562019-03-07
00192896123427Trocar20910-1120910-112026-06-02

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Primary DI, Brand, Company table
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00840319759202Hayden MedicalHayden Medical, Inc.HNR2026-07-30
00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30
03701089543286AMPLITUDEAMPLITUDE SASGDJ2026-07-29
00190776422196MillenniumAvalign Technologies, Inc.GDJ2026-07-28
B382SD9055891030Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
B382SD905589105T0Surgical DirectSurgical Direct, Inc.GDJ2026-07-28
00859261006265VBAS Extension ArmVYCOR MEDICAL, INC.GDJ2026-07-27
G2231114060Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G2231119000Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G223111901T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
G22312408910Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNR2026-07-27
00190776405854MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776405878MillenniumAvalign Technologies, Inc.HNR2026-07-26
00190776404178MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776404185MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776398675MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776400248MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403287MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403294MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403690MillenniumAvalign Technologies, Inc.HNR2026-07-21
00190776403737MillenniumAvalign Technologies, Inc.HNR2026-07-21
00810220800461Adler Instrument CompanyAdler, Inc.DXC2026-07-17
00190776397180MillenniumAvalign Technologies, Inc.DXC2026-07-16