FDA.reportPublic FDA data

gSource

Primary DI
00840314209627
Brand
gSource
Company
GSOURCE LLC
Model
gS 27.0110
Catalog number
gS 27.0110
Device description
Lewis Lens Loop 5 1/2", 4x7mm smooth
Published
2020-01-08
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

Product Codes#

Code, Name table
CodeName
JYQLoop, Wire

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JYQLoop, WireEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840314209627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314209627008403142096278403142096270840314209627

GMDN Terms#

Term, Definition table
TermDefinition
Lens loop, reusableA hand-held, manual, ophthalmic surgical instrument designed for eye lens extraction and gentle manipulation and/or irrigation of eye tissues during an ophthalmic surgical procedure. It typically consists of a small wire loop (frequently serrated) at the distal tip and a handle for easy manipulation; it may also include a channel (e.g., a cannula) which is connected to an external irrigator for irrigation of the eye. This is a reusable device.

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770409921Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770416196Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770423514Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00757770433087Bausch + LombBausch & Lomb IncorporatedJYQ2025-08-05
00194613033118MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033125MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613033132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613046132MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089160MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613089313MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613106270MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613108007MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00194613112240MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-08-01
00840343726430GEN2SURGIX MEDICAL LLCJYQ2025-06-16
00190776401160MillenniumAvalign Technologies, Inc.JYQ2025-06-10
00194613089320MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
00194613107994MSI Precision Specialty InstrumentsMed Saver, Inc.JYQ2025-03-21
10840306828116Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-02-12
10840306828192Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
10840306828239Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2025-01-20
G22313930920Medetz Surgical InstrumentsMedetz Surgical Instruments LLCJYQ2025-01-14
10840306828130Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.JYQ2024-12-10
04049197309271RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197312486RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321419RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321457RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197321464RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197474399RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
04049197477796RZ Medizintechnik GmbHRZ-Medizintechnik GmbHJYQ2024-09-20
00887482112892Symmetry Surgical®SYMMETRY SURGICAL INC.JYQ2024-08-12