FDA.reportPublic FDA data

JAYSEN BAYONET EAR FORCEPS

Primary DI
00192896099326
Brand
JAYSEN BAYONET EAR FORCEPS
Company
SONTEC INSTRUMENTS, INC.
Model
467-315Q
Catalog number
467-315Q
Device description
JAYSEN BAYONET EAR FORCEPS
Published
2020-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KAEFORCEPS, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896099326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896099326001928960993261928960993260192896099326

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.5Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization;Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-7496info@sontecinstruments.com

Regulatory Flags#

DUNS number
040729840
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192896015104REEH STITCH SCISSORS13-832513-83252018-09-12
00192896062238RYDER NEEDLE HOLDER2300-3152300-3152018-09-12
00192896105171Small Plates355-236A355-236A2020-10-05
00192896122833Intraocular Set1100-034-SET1100-034-SET2026-03-19
00192896122840Alyea-Babcock Vasectomy Clamp516-695516-6952026-03-19
00192896122857Diamond Head Grasping Forceps1273-1251273-1252026-03-19
00192896122864Velociraptor Junior Rongeur1273-171F1273-171F2026-03-19
00192896122871Spoon Curette2900-2222900-2222026-03-19
00192896122888Dissector2900-2332900-2332026-03-19
00192896122895Ball Dissector2900-2352900-2352026-03-19
00192896122901Hook Dissector2900-2372900-2372026-03-19
00192896122918Hook Dissector2900-2382900-2382026-03-19
00192896122925Spatula Dissector2900-2422900-2422026-03-19
00192896122932Spatula Dissector2900-2442900-2442026-03-19
00192896122949Deluxe Alligator Grasping Forceps1100-333D1100-333D2026-03-19
00192896122680Schroeder Vulsellum Bone Clamp1103-0641103-0642026-03-10
00192896122697Cooley Vascular Clamp2100-527C2100-527C2026-03-10
00192896122703Ochsner Dissector2700-155T2700-155T2026-03-10
00192896122710Debakey Coarctation Clamp2100-6312100-6312026-03-10
00192896122727Debakey Coarctation Clamp2100-6352100-6352026-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811103338INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-16
09348811103321INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-03-09
24026704934472PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934489PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934502PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934519PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934526PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934533PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934540PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934557PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934571PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934588PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934625PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
24026704934632PILLINGTELEFLEX INCORPORATEDKAE2026-03-06
00810123209842Adler Instrument CompanyAdler, Inc.KAE2026-03-03
00190776417413MillenniumAvalign Technologies, Inc.KAE2026-02-27
00190776417468MillenniumAvalign Technologies, Inc.KAE2026-02-27
00848657078214AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
00848657078221AEDNATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KAE2026-02-18
09008737448905SoftGrip Forceps 2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
09008737448912SoftGrip Forceps SR2Med-El Elektromedizinische Geräte Gesellschaft m.b.H.KAE2026-02-04
G04362076B0BEARBear-Ent, LLCKAE2026-02-03
09348811103659INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
09348811103673INKAThe Trustee for KAISER FAMILY TRUSTKAE2026-01-28
04046826104276Medicon ForcepsMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2025-12-15
09348811105424INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811129017INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-02
09348811104199INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104229INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01
09348811104328INKAThe Trustee for KAISER FAMILY TRUSTKAE2025-12-01