FDA.reportPublic FDA data

ProDentUSA

Primary DI
00810058670595
Brand
ProDentUSA
Company
Professional Surgical Instruments Co., Inc.
Model
GS12-12600
Device description
"Operating Scissors 5.5"" Straight, Sharp/Sharp, German Stainless Steel"
Published
2026-03-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810058670595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810058670595008100586705958100586705950810058670595

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA 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 reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length5.5Inch

Sterilization Methods#

Method table
Method
"[""Moist Heat or Steam Sterilization"", ""Ethylene Oxide""]"

Regulatory Flags#

DUNS number
197354343
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
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
00810097679238Professional Surgical Instruments Co., Inc. 11-118002026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776422202MillenniumAvalign Technologies, Inc.LRW2026-07-28
00198506092800ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093036ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093326ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
00198506093401ELMED INCORPORATEDELMED INCORPORATEDLRW2026-07-28
B382SD9037871020Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871030Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9037871090Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741050Surgical DirectSurgical Direct, Inc.LRW2026-07-28
B382SD9038741100Surgical DirectSurgical Direct, Inc.LRW2026-07-28
00190776405915MillenniumAvalign Technologies, Inc.LRW2026-07-26
00190776422028MillenniumAvalign Technologies, Inc.LRW2026-07-24
00190776421908MillenniumAvalign Technologies, Inc.LRW2026-07-23
00190776421922MillenniumAvalign Technologies, Inc.LRW2026-07-23
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
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