FDA.reportPublic FDA data

Professional Surgical Instruments Co., Inc.

Primary DI
00853863007576
Brand
Professional Surgical Instruments Co., Inc.
Company
Professional Surgical Instruments Co., Inc.
Model
OM-R7180
Device description
"4.5"" Iris Straight, Satin, w/PP and Wire Tissue Forceps"
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
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10853863007573PackageGS1500In Commercial Distribution
00853863007576PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085386300757310853863007573
00853863007576008538630075768538630075760853863007576

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
197354343
Device count
1
Premarket exempt
true
Kit
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
00724995268848Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268855Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268862Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268879Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268886Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268893Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
00724995268909Snowden-PencerSTERIS Deutschland GmbHLRW2026-09-25
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
00190776432355MillenniumAvalign Technologies, Inc.LRW2026-09-24
00810238290001PRINCETONPrinceton Medical Group, Inc.LRW2026-09-22
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