FDA.reportPublic FDA data

FORCEPS

Primary DI
00192896102002
Brand
FORCEPS
Company
SONTEC INSTRUMENTS, INC.
Model
14-5549
Device description
O'Gawa Forceps With Tying Platform Round Handle Straight Tip Stainless Steel
Published
2020-05-18
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
HNRForceps, ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896102002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896102002001928961020021928961020020192896102002

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical device handling forcepsA hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. It has a tweezers-like design (may be a micro/fine instrument) with two blades joined at the proximal (non-working) end which have variously designed tips at the working end, typically with a slot/groove to accept the ophthalmic device; it is made of metal and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00192896123434Flexible Trocar Sleeve15-16141-0315-16141-032026-06-02
00192896123441Barraquer Anis Needle Holder15-3810Q15-3810Q2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398668MillenniumAvalign Technologies, Inc.HNR2026-07-16
00190776398699MillenniumAvalign Technologies, Inc.HNR2026-07-16
00860015282002Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282019Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282026Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282033Intrace USAPILOTIS TECH LLCHNR2026-07-03
00860015282071Intrace USAPILOTIS TECH LLCHNR2026-07-03
05060411983007Capsulorhexis Forceps, Utrata Tips, 12mm Curved Shafts, Round HandlesDTR MEDICAL LIMITEDHNR2026-06-10
00840285320789Walcott Rx ProductsWalcott Rx Product IncHNR2026-06-05
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17
G006D502002S0STORZ Utrata Capsulorhexis ForcepsDAUD JEE MFG. COHNR2022-12-17
G006D5011895010COLIBRI FORCEP 0.12 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5011895020COLIBRI FORCEP 0.4 W/TYING PLATFORMDAUD JEE MFG. COHNR2022-12-13
G006D5019300STORZ CASTROVEIJO COLIBRI FORCEPS 0.12DAUD JEE MFG. COHNR2022-12-13
G006D5023500HOFFER-MCPHERSON FORCEPS DEL 11M LONG JAWSDAUD JEE MFG. COHNR2022-12-13
G006D5025000CASTROVIEJO FORCEPS 0.12MM DAUD JEE MFG. COHNR2022-12-13
G006D5025100CASTROVIEJO FORCEPS 0.3MM DAUD JEE MFG. COHNR2022-12-13
G006D5025200CASTROVIEJO FORCEPS 0.5MM DAUD JEE MFG. COHNR2022-12-13
G006D5025300CASTROVIEJO FORCEPS 0.9MM DAUD JEE MFG. COHNR2022-12-13
G006D50253000CASTROVIEJO FORCEPS 0.12MM DAUD JEE MFG. COHNR2022-12-13
G006D502530010CASTROVIEJO FORCEPS 0.3MM DAUD JEE MFG. COHNR2022-12-13
G006D5023000MCPHERSON FORCEPS 1X2 STR DAUD JEE MFG. COHNR2022-12-12
G006D5023100MCPHERSON FORCEPS 1X2 ANG DAUD JEE MFG. COHNR2022-12-12
G006D5023300KELMAN-MCPHERSON FORCEPS 8MM LONG JAWS, 0.3MMDAUD JEE MFG. COHNR2022-12-12
G006D5011895030COLIBRI FORCEP 0.12 W/TYING PLATFORM OBLIQUEDAUD JEE MFG. COHNR2022-12-10
G006D50131600French M patern Corneal forceps, delicate, 1x2 , 0.12DAUD JEE MFG. COHNR2022-12-10
G006D5015660HOFMANN-POLACK SUTURING FORCEPS 0.2MMDAUD JEE MFG. COHNR2022-12-10