FDA.reportPublic FDA data

PITANGUY MARKING FORCEPS

Primary DI
00192896043091
Brand
PITANGUY MARKING FORCEPS
Company
SONTEC INSTRUMENTS, INC.
Model
475-846
Catalog number
475-846
Device description
PITANGUY MARKING FORCEPS SERRATED TIP
Published
2018-09-14
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
KAEFORCEPS, ENT

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896043091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896043091001928960430911928960430910192896043091

GMDN Terms#

Term, Definition table
TermDefinition
Mastoid rongeurA surgical instrument designed to remove hard or tough tissues (e.g., bone or cartilage) around the mastoid process (the large projection of the temporal bone of the skull found immediately behind each ear) by applying a biting/cutting action during ear/nose/throat (ENT) surgery. It is has a forceps or pliers-like design terminating at the distal end with sharp-edged, scoop-shaped, narrow jaws attached to strong, sprung (self-opening), pivoted handles that, when squeezed together, close the jaws to bite (cut) through the mastoid tissue. It is available in various sizes and is made of high-grade stainless steel and designed to withstand the forces which are applied. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length6.5Inch

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
+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
00192896123861Sheen Mini Cartilage Cutting Block350-845M350-845M2026-10-14
00192896123878Allis Tissue Forceps140-331Q140-331Q2026-10-14
00192896123885Allis Tissue Forceps140-330AQ140-330AQ2026-10-14
00192896123892Ceramitec Debakey Forceps2200-168CL2200-168CL2026-10-14
00192896123908Debakey Forceps2200-168L2200-168L2026-10-14
00192896123915Ceramitec Debakey Forceps2200-172CL2200-172CL2026-10-14
00192896123922Knurled Nut2500-200-1B2500-200-1B2026-10-14
00192896123939Bishop Harmon Tissue Forceps14-380114-38012026-10-14
00192896097049Laparoscopic Bulldog Clamp Forceps2901-2812901-2812019-05-09
00192896097056Laparoscopic Bulldog Clamp2901-281-252901-281-252019-05-09
00192896097063Laparoscopic Bulldog Clamp2901-281-402901-281-402019-05-09
00192896123793Adson Tissue Forceps140-302DLQ140-302DLQ2026-10-06
00192896123809Micro Skinner Forceps140-519M140-519M2026-10-06
00192896123816Jacobson Needle Holder2300-142D2300-142D2026-10-06
00192896123823Thumb Dressing Forceps136-610Q136-610Q2026-10-06
00192896123830Thumb Dressing Forceps136-615Q136-615Q2026-10-06
00192896123847Thumb Dressing Forceps136-619Q136-619Q2026-10-06
00192896123854Gum Scissors475-153Q475-153Q2026-10-06
00192896111394Laparoscopic Bulldog Clamp2901-281-60T2901-281-60T2021-10-22
00192896056282ALLIGATOR FORCEPS1271-0101271-0102018-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435554MillenniumAvalign Technologies, Inc.KAE2026-10-20
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B382SD309390Surgical DirectSurgical Direct, Inc.KAE2026-10-20
00190776435196MillenniumAvalign Technologies, Inc.KAE2026-10-16
00810220800638Adler Instrument CompanyAdler, Inc.KAE2026-10-15
04250603753230LAZICPeter Lazic GmbHKAE2026-10-15
00190776436322MillenniumAvalign Technologies, Inc.KAE2026-10-08
00724995267926Snowden-PencerSTERIS Deutschland GmbHKAE2026-09-25
00724995271466V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995274955V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275013V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275020V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275037V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275044V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275051V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275068V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275075V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995330002V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
04046826110932MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-09-24
G141550875300Carnegie Surgical LLCCarnegie Surgical LLCKAE2026-09-19
00190776420413MillenniumAvalign Technologies, Inc.KAE2026-08-26
00190776420420MillenniumAvalign Technologies, Inc.KAE2026-08-26
04054462901692evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901708evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901715evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901722evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901739evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901746evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901760evonosevonos GmbH & Co. KGKAE2026-08-21