FDA.reportPublic FDA data

ProDentUSA

Primary DI
00810097676978
Brand
ProDentUSA
Company
Professional Surgical Instruments Co., Inc.
Model
GS12-005TC
Device description
"Goldman Fox Scissors 5"" Straight, German Stainless Steel, Tungsten Carbide Blades"
Published
2026-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EGNScissors, Surgical Tissue, Dental
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810097676978PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810097676978008100976769788100976769780810097676978

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"
Moist Heat or Steam Sterilization;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
00810058670519ProDentUSAGS10-102002026-02-12
00810058670533Professional Surgical Instruments Co., Inc. 11-120002026-02-12
00810097679238Professional Surgical Instruments Co., Inc. 11-118002026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776403256MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403300MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776403669MillenniumAvalign Technologies, Inc.LRW2026-07-21
00190776400392MillenniumAvalign Technologies, Inc.LRW2026-07-17
00840183531546BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531553BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531577BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531614BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531645BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183531706BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183532406BR Surgical, LLCBR Surgical, LLCLRW2026-07-17
00840183532413BR Surgical, LLCBR Surgical, LLCEGN2026-07-17
04058749007428NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749045383NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749048131NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749121131NAFehling Instruments GmbH & Co. KGLRW2026-07-17
04058749121148NAFehling Instruments GmbH & Co. KGLRW2026-07-17
B382SD9074751070Surgical DirectSurgical Direct, Inc.EGN2026-07-17
B382SD9084541040Surgical DirectSurgical Direct, Inc.EGN2026-07-17
00190776397081MillenniumAvalign Technologies, Inc.LRW2026-07-16
00840183531850BR Surgical, LLCBR Surgical, LLCLRW2026-07-16
00840183531966BR Surgical, LLCBR Surgical, LLCLRW2026-07-16
00190776395575MillenniumAvalign Technologies, Inc.LRW2026-07-14
00190776395582MillenniumAvalign Technologies, Inc.LRW2026-07-14
B382SD903988102SC0Surgical DirectSurgical Direct, Inc.EGN2026-07-14
B382SD9039991090Surgical DirectSurgical Direct, Inc.EGN2026-07-14
04059453162618Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-07-13
00850088713022PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713060PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10
00850088713077PRINCETONPrinceton Medical Group, Inc.LRW2026-07-10