FDA.reportPublic FDA data

GRASPING FORCEPS

Primary DI
00192896100312
Brand
GRASPING FORCEPS
Company
SONTEC INSTRUMENTS, INC.
Model
516-007
Device description
FOREIGN BODY REMOVAL/GRASPING FORCEPS RING HANDLE SERRATED JAW
Published
2020-02-24
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
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192896100312PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192896100312001928961003121928961003120192896100312

GMDN Terms#

Term, Definition table
TermDefinition
Stone/foreign-body extraction setA collection of surgical instruments intended to remove calculi, debris, and/or to retrieve fragments of catheter tubing, wire guides, pull wires, plastic stents and other foreign bodies during urological and/or gastroenterological interventions. It typically consists of a retrieval basket and/or grasping forceps, an introducing sheath or sleeve, and possibly a guidewire; the exact design of the set will vary depending on the surgical method. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length40Centimeter

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422844MillenniumAvalign Technologies, Inc.HTD2026-08-03
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00190776422349MillenniumAvalign Technologies, Inc.HTD2026-07-31
00810143904567SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906158SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906349SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906356SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906448SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931029SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931036SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931043SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931050SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931913SURGIPROSSurgipros, LLCHTD2026-07-31
00810212934907SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935133SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935638SURGIPROSSurgipros, LLCHTD2026-07-31
B382S028531010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S028531030Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S28531800Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S8541010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382SD1355500Surgical DirectSurgical Direct, Inc.HTD2026-07-31
00840277133724Innomed, Inc.INNOMED, INC.HTD2026-07-29
B382SD92022614E0Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9203561000Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9206011020Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B3825SD918621130Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493210Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493220Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD918493230Surgical DirectSurgical Direct, Inc.HTD2026-07-28
B382SD91849612000Surgical DirectSurgical Direct, Inc.HTD2026-07-28