FDA.report

gSource

Primary DI
00840314200938
Brand
gSource
Company
GSOURCE LLC
Model
gS 13.2385
Catalog number
gS 13.2385
Device description
Iris Scissors 4" cvd b/b
Published
2019-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LRWScissors, General, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840314200938PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314200938008403142009388403142009380840314200938

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
008162518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24
00840314238627gSourcegS 75.9307gS 75.93072025-11-24
00840314238634gSourcegS 75.9308gS 75.93082025-11-24
00840314238641gSourcegS 75.9309gS 75.93092025-11-24
00840314238658gSourcegS 75.9310gS 75.93102025-11-24

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810220800003Adler Instrument CompanyAdler, Inc.LRW2026-03-17
00810158219366PRINCETONPrinceton Medical Group, Inc.LRW2026-03-12
00190776394127MillenniumAvalign Technologies, Inc.LRW2026-03-11
00190776417833MillenniumAvalign Technologies, Inc.LRW2026-03-11
00810158218987PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158218994PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00810158219168PRINCETONPrinceton Medical Group, Inc.LRW2026-03-11
00192896122734Metzenbaum ScissorsSONTEC INSTRUMENTS, INC.LRW2026-03-10
04058749117462NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749121995NAFehling Instruments GmbH & Co. KGLRW2026-03-05
04058749122008NAFehling Instruments GmbH & Co. KGLRW2026-03-05
00198506088605ELMED INCORPORATEDELMED INCORPORATEDLRW2026-02-23
00190776417277MillenniumAvalign Technologies, Inc.LRW2026-02-20
00190776417291MillenniumAvalign Technologies, Inc.LRW2026-02-20
00810058670540ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00810058670557ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00810058670564ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00810097677043ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-18
00840306837340Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LRW2026-02-18
00840306837357Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.LRW2026-02-18
00810097676947ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676954ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676961ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
00810097676978ProDentUSAProfessional Surgical Instruments Co., Inc.LRW2026-02-17
G4254009010My MedicalMy Medical Store LLCLRW2026-02-17
G425400913SCP0My MedicalMy Medical Store LLCLRW2026-02-17
00810158218918PRINCETONPrinceton Medical Group, Inc.LRW2026-02-16
04059453062468Hermann Medizintechnik GmbHHermann Medizintechnik GmbHLRW2026-02-13
09348811000873INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-13
09348811000897INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-13