FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770433414
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E0649
Catalog number
E0649
Device description
LOOP LENS OLIVE GILLS - WELSH
Published
2025-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HNSExpressor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNSExpressorOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770433414PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770433414007577704334147577704334140757770433414

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
196603781
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00041533986119BruderThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986201Bruder LivengoodThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986300Bruder LivengoodThe Hilsinger Company Parent, LlcHNS2026-02-25
00041533986126Bruder The Hilsinger Company Parent, LlcHNS2025-11-21
00041533986133BruderThe Hilsinger Company Parent, LlcHNS2025-11-21
00041533986102Bruder CollinsThe Hilsinger Company Parent, LlcHNS2025-10-20
00757770402939Bausch + LombBausch & Lomb IncorporatedHNS2025-08-08
00757770418466Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770418473Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770429158Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00194613101411MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613101428MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-08-01
00194613113315MSI Precision Specialty InstrumentsMed Saver, Inc.HNS2025-03-21
00757770419944Bausch + LombBausch & Lomb IncorporatedHNS2024-12-30
00757770535545Bausch + LombBausch & Lomb IncorporatedHNS2024-11-20
G2231112380Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNS2023-09-25
00858027006389TearCare(R) Clearance Assistant PLUSSight Sciences, Inc.HNS2023-08-22
00190660034948Ambler SurgicalAMBLER SURGICAL CORP.HNS2021-01-07
00190660034955Ambler SurgicalAMBLER SURGICAL CORP.HNS2021-01-07
00190660034962Ambler SurgicalAMBLER SURGICAL CORP.HNS2021-01-07
B5821051631140N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821058710N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821058800N/AGEORGE TIEMANN & CO.HNS2020-09-24
B582105901H0N/AGEORGE TIEMANN & CO.HNS2020-09-24
B582105901K0N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059040N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059050N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059060N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059100N/AGEORGE TIEMANN & CO.HNS2020-09-24
B58210591010N/AGEORGE TIEMANN & CO.HNS2020-09-24