FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770429158
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E0648
Catalog number
E0648
Device description
LOOP LENS LEWIS
Published
2025-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00757770429158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770429158007577704291587577704291580757770429158

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
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
00757770406791Bausch + LombSP7-100227SP7-1002272026-02-11
00757770421848Bausch + LombSP7-100220SP7-1002202026-02-11
00757770428588Bausch + LombSP7-35740SP7-357402026-02-11
00757770676491Bausch + LombSP7-69525SP7-695252026-02-11
00757770682539Bausch + LombSP7-68756SP7-687562026-02-11
00757770712281Bausch + LombSP7-36090SP7-360902026-02-11
00757770714049Bausch + LombSP7-64085SP7-640852026-02-11
00757770714056Bausch + LombSP7-71927SP7-719272026-02-11
00757770425044Bausch + LombSP7-35203SP7-352032026-02-04
00757770429301Bausch + LombSP7-100217SP7-1002172026-02-04
00757770636631Bausch + LombSP7-62478SP7-624782026-02-04
00757770668427Bausch + LombSP7-66972SP7-669722026-02-04
00757770683741Bausch + LombSP7-70000SP7-700002026-02-04
00757770708260Bausch + LombSP7-55555SP7-555552026-02-04
00757770635382Bausch + LombE0130 1.8/2.2E0130 1.8/2.22026-01-27
00310119041024Bausch + Lomb623890FCP-4278A2026-01-09
00310119041062Bausch + Lomb623995FCP-43732026-01-09
00310119041086Bausch & Lomb624423FCP-43602026-01-09
00310119041406Bausch + Lomb623909FCP-4278A2026-01-09
00310119041420Bausch + Lomb623994FCP-43732026-01-09

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
00757770402939Bausch + LombBausch & Lomb IncorporatedHNS2025-08-08
00757770418466Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770418473Bausch + LombBausch & Lomb IncorporatedHNS2025-08-05
00757770433414Bausch + 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
B58210591090N/AGEORGE TIEMANN & CO.HNS2020-09-24
B582105910NP0N/AGEORGE TIEMANN & CO.HNS2020-09-24
B5821059110N/AGEORGE TIEMANN & CO.HNS2020-09-24