FDA.reportPublic FDA data

gSource

Primary DI
00840314251114
Brand
gSource
Company
GSOURCE LLC
Model
U1.13.1680
Catalog number
U1.13.1680
Device description
"gU Iris Scissors 4 1/2"" str pkg/10"
Published
2025-09-08
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
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
00840314251114PrimaryGS10
00840314269904Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314251114008403142511148403142511140840314251114
00840314269904008403142699048403142699040840314269904

GMDN Terms#

Term, Definition table
TermDefinition
Intraocular scissors, conventional-hinge, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut intraocular tissue of the anterior segment (e.g., iris). It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (i.e., not a probe-like device). It is typically metallic, may have ring handles or spring handles, and is available with various blade designs and sizes. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
008162518
Device count
10
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314270351gSourcegS 87.5216gS 87.52162026-10-22
00840314210364gSourcegS 29.4468gS 29.44682026-10-09
00840314252449gSourcegS 17.4346gS 17.43462026-10-09
00840314218117gSourcegS 40.6990gS 40.69902019-12-20
00840314243782gSourcegS 82.4740gS 82.47402020-02-27
00840314220448gSourcegS 42.7171gS 42.71712019-12-27
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314222237gSourcegS 45.5033gS 45.50332020-01-02
00840314222244gSourcegS 45.5043gS 45.50432020-01-02
00840314222251gSourcegS 45.5060gS 45.50602020-01-02
00840314231598gSourcegS 59.7670gS 59.76702020-02-14
00840314242723gSourcegS 81.3716gS 81.37162020-02-26
00840314242730gSourcegS 81.3717gS 81.37172020-02-26
00840314233073gSourcegS 65.7440gS 65.74402020-02-18
00840314243874gSourcegS 82.4870gS 82.48702020-02-27
00840314246295gSourcegS 86.4420gS 86.44202020-03-03
00840314246349gSourcegS 86.4530gS 86.45302020-03-03
00840314221278gSourcegS 43.4120gS 43.41202019-12-31
00840314270344gSourcegS 40.1143gS 40.11432026-09-22
00840314269744gSourcegS 59.1800gS 59.18002025-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435639MillenniumAvalign Technologies, Inc.LRW2026-10-21
00190776436797MillenniumAvalign Technologies, Inc.LRW2026-10-21
00190776435479MillenniumAvalign Technologies, Inc.LRW2026-10-20
00190776436629MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776436728MilleniumAvalign Technologies, Inc.LRW2026-10-20
00190776439712MilleniumAvalign Technologies, Inc.LRW2026-10-20
B356111PL87514ST0steriSTATAmerican MedicalsLRW2026-10-20
00190776435325MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435332MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435400MillenniumAvalign Technologies, Inc.LRW2026-10-19
00190776435189MillenniumAvalign Technologies, Inc.LRW2026-10-16
00190776434915MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435042MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435059MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435066MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776435073MillenniumAvalign Technologies, Inc.LRW2026-10-14
00190776434649MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776434793MillenniumAvalign Technologies, Inc.LRW2026-10-12
00190776433864MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436278MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776436292MillenniumAvalign Technologies, Inc.LRW2026-10-08
00190776433635MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434403MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434496MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434502MillenniumAvalign Technologies, Inc.LRW2026-10-07
00190776434519MillenniumAvalign Technologies, Inc.LRW2026-10-07
G141510457190Carnegie Surgical LLCCarnegie Surgical LLCLRW2026-10-07
00190776433987MillenniumAvalign Technologies, Inc.LRW2026-10-06
00190776433994MillenniumAvalign Technologies, Inc.LRW2026-10-06
10841767100537Trinity Sterile, Inc.Trinity Sterile, Inc.LRW2026-10-06