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

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896102477SONTEC PIN CUTTER355-207355-2072020-06-08
00192896100787ANTRUM GRASPING FORCEPS468-361468-3612020-02-24
00192896040892ANTRUM GRASPING FORCEPS468-362468-3622018-09-12
00192896045743TURNER WARWICK UROLOGICAL RETRACTOR RING516-804R516-804R2018-09-18
00192896080799TURNER WARWICK UROLOGICAL RETRACTOR BLADE516-804BA516-804BA2018-09-20
00192896080805TURNER WARWICK UROLOGICAL RETRACTOR BLADE516-804BB516-804BB2018-09-20
00192896080812TURNER WARWICK UROLOGICAL RETRACTOR BLADE516-804BC516-804BC2018-09-20
00192896045736TURNER WARWICK UROLOGICAL RETRACTOR516-8042-SET516-8042-SET2018-09-17
00192896123946Micro Osteotome475-7864475-78642026-10-27
00192896123953Laparoscopic Bulldog Clamp2901-281-452901-281-452026-10-27
00192896123960Laparoscopic Bulldog Clamp2901-281-602901-281-602026-10-27
00192896123977Yankauer Pediatric Suction Tube180-446180-4462026-10-27
00192896123984Trepsat Flap Dissecting Forceps438-635G438-635G2026-10-27
00192896123991Trepsat Flap Dissecting Forceps438-636G438-636G2026-10-27
00192896124004Trepsat Flap Dissecting Forceps438-637G438-637G2026-10-27
00192896124011Debakey Beck Clamp2100-7872100-7872026-10-27
00192896124028Debakey Beck Clamp2100-7882100-7882026-10-27
00192896040885Antrum Grasping Forceps468-360468-3602018-09-10
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810238290186PRINCETONPrinceton Medical Group, Inc.GDJ2026-10-29
M944AL1186120Wexler Surgical, Inc.WEXLER SURGICAL, INC.GDJ2026-10-29
07612717072169FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072176FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
07612717072190FINESSE REFLEXAlcon Laboratories, Inc.HNR2026-10-28
B382SD902769010Surgical DirectSurgical Direct, Inc.HNR2026-10-28
00192896124011Debakey Beck ClampSONTEC INSTRUMENTS, INC.DXC2026-10-27
00192896124028Debakey Beck ClampSONTEC INSTRUMENTS, INC.DXC2026-10-27
00724995266707Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266714Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266721Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266738Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266745Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266769Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266776Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995266783Snowden-PencerSTERIS Deutschland GmbHHNR2026-10-27
00724995316280V. MuellerSTERIS Deutschland GmbHHNR2026-10-27
00190776437039MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437046MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776437053MillenniumAvalign Technologies, Inc.HNR2026-10-23
00190776436841MillenniumAvalign Technologies, Inc.GDJ2026-10-22
00190776435721MillenniumAvalign Technologies, Inc.HNR2026-10-21
04251852767368Bulldog clampAckermann Instrumente GmbHGDJ2026-10-21
00190776436636MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436643MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436681MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776437763MillenniumAvalign Technologies, Inc.DXC2026-10-20
00190776435226MillenniumAvalign Technologies, Inc.DXC2026-10-19
00190776435318MillenniumAvalign Technologies, Inc.HNR2026-10-19
G346EA32C0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-10-16