FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770418473
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E0644
Catalog number
E0644
Device description
LOOP LENS WILDER
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
00757770418473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770418473007577704184737577704184730757770418473

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
00757770454747Bausch + LombCX7120CX71202016-09-24
00757770425723Bausch + LombN1705 93N1705 932025-08-22
00757770420797Bausch + LombN2485N24852025-08-15
00757770423194Bausch + LombE3048E30482025-08-15
00757770407712Bausch + LombX0750 21X0750 212025-08-05
00757770683505Bausch + LombSP7-72199SP7-721992025-08-05
00757770424443Bausch + LombN6065 0N6065 02025-07-29
00757770429974Bausch + LombN6065 1N6065 12025-07-29
00757770430055Bausch + LombN6065 3N6065 32025-07-29
00757770404575Bausch + LombN0902N09022025-07-28
00757770405077Bausch + LombN0964N09642025-07-28
00757770406227Bausch + LombN0950N09502025-07-28
00757770408368Bausch + LombN0965N09652025-07-28
00757770409068Bausch + LombN0986N09862025-07-28
00757770417070Bausch + LombN0958N09582025-07-28
00757770420636Bausch + LombN0970N09702025-07-28
00757770426546Bausch + LombN0982N09822025-07-28
00757770411610Bausch + LombN1685 D 1N1685 D 12025-06-03
00757770520183BLIS-X1BLIS-X12024-03-04
00757770523337BLIS-X0BLIS-X02024-03-04

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
00757770429158Bausch + 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