FDA.reportPublic FDA data

Professional Surgical Instruments Co., Inc.

Primary DI
00853863007804
Brand
Professional Surgical Instruments Co., Inc.
Company
Professional Surgical Instruments Co., Inc.
Model
OMS2629-5C
Device description
"5"" 1x2 Tissue Forceps Insert, Wire Form"
Published
2025-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
10853863007801PackageGS1300In Commercial Distribution
00853863007804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085386300780110853863007801
00853863007804008538630078048538630078040853863007804

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, single-useA 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 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 single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
197354343
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
00810058670595ProDentUSAGS12-126002026-03-27
00810097678316ProDentUSAGS12-122TC2026-03-27
00810097678323ProDentUSAGS12-126TC2026-03-27
00810097678330ProDentUSAGS12-127002026-03-27
00810097678347ProDentUSAGS12-127TC2026-03-27
00810097678354ProDentUSAGS12-129002026-03-27
00810097678361ProDentUSAGS12-129TC2026-03-27
00810097678378ProDentUSAGS12-132002026-03-27
00810097678385ProDentUSAGS12-132TC2026-03-27
00853863007040ProDentUSAGS12-122002026-03-27
00810058670540ProDentUSAGS12-065002026-02-18
00810058670557ProDentUSAGS12-067002026-02-18
00810058670564ProDentUSAGS12-105002026-02-18
00810097677043ProDentUSAGS12-070002026-02-18
00810097676947ProDentUSAGS12-005002026-02-17
00810097676954ProDentUSAGS12-005102026-02-17
00810097676961ProDentUSAGS12-0051TC2026-02-17
00810097676978ProDentUSAGS12-005TC2026-02-17
00810058670519ProDentUSAGS10-102002026-02-12
00810058670533Professional Surgical Instruments Co., Inc. 11-120002026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995323578V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323585V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323608V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
00724995323615V. MuellerSTERIS Deutschland GmbHHTD2026-09-25
10886982357298VOLTSynthes GmbHHTD2026-09-25
10886982357304VOLTSynthes GmbHHTD2026-09-25
10886982357311VOLTSynthes GmbHHTD2026-09-25
10886982357328VOLTSynthes GmbHHTD2026-09-25
10886982357854VOLTSynthes GmbHHTD2026-09-25
10886982357861VOLTSynthes GmbHHTD2026-09-25
10886982357878VOLTSynthes GmbHHTD2026-09-25
10886982357885VOLTSynthes GmbHHTD2026-09-25
00810238290063PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00810238290087PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713916PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713930PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00850088713947PRINCETONPrinceton Medical Group, Inc.HTD2026-09-22
00190776431082MillenniumAvalign Technologies, Inc.HTD2026-09-21
00190776430962MillenniumAvalign Technologies, Inc.HTD2026-09-18
00192896123755Debakey-Diethrich Tissue ForcepsSONTEC INSTRUMENTS, INC.HTD2026-09-18
00190776424015MillenniumAvalign Technologies, Inc.HTD2026-08-27
00192896123632Adson Dressing ForcepsSONTEC INSTRUMENTS, INC.HTD2026-08-27
00190776419738MillenniumAvalign Technologies, Inc.HTD2026-08-25
00850088713596PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
00850088713619PRINCETONPrinceton Medical Group, Inc.HTD2026-08-25
04054462901821evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901852evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901869evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901876evonosevonos GmbH & Co. KGHTD2026-08-21
04054462901883evonosevonos GmbH & Co. KGHTD2026-08-21