FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770500444
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E9105
Catalog number
E9105
Device description
MACRAE LASEK WELL 6.5 MM
Published
2025-08-08
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
HNXDepressor, Orbital

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNXDepressor, OrbitalOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770500444PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770500444007577705004447577705004440757770500444

GMDN Terms#

Term, Definition table
TermDefinition
LASEK alcohol well, reusableA hand-held, manual, ophthalmic surgical device designed to hold a small reservoir of alcohol solution at the surface of the cornea to soften the corneal epithelium for subsequent epithelial flap creation during laser-assisted epithelial keratomileusis (LASEK) surgery. It may additionally be designed to hold/assist placement of the dedicated trephine (cylindrical cutting blade) at the surface of the eye during flap creation. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
196603781
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00757770472222Bausch + LombMVS1083MVS10832016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G223A1140970Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNX2026-08-03
04547451339212INAMIINAMI & CO., LTD.HNX2026-01-29
04547451339045InamiINAMI & CO., LTD.HNX2025-12-05
04058935013394Depressor Scleral FlynnBausch & Lomb GmbHHNX2025-10-26
00757770483235Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770498765Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00757770524914Bausch + LombBausch & Lomb IncorporatedHNX2025-08-08
00194613011604MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613011628MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
00194613109738MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-08-01
G412DP20600MR PHACOCrestpoint Management LimitedHNX2025-05-27
00194613119959MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2025-03-21
00757770406685Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770414703Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770425136Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770432097Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00757770435326Bausch + LombBausch & Lomb IncorporatedHNX2024-11-20
00192896120273Schepens Scleral DepressorSONTEC INSTRUMENTS, INC.HNX2024-10-15
00757770426676Bausch + LombBausch & Lomb IncorporatedHNX2024-08-26
00887482049297Symmetry HarmsASPEN SURGICAL PRODUCTS, INC.HNX2024-08-20
00194613087753MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087760MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087777MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00194613087821MSI Precision Specialty InstrumentsMed Saver, Inc.HNX2024-08-15
00887482111475Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111482Symmetry SchepensASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00887482111499Symmetry FlynnASPEN SURGICAL PRODUCTS, INC.HNX2024-08-12
00840183521998BR Surgical, LLCBR Surgical, LLCHNX2024-06-03
08175700156110Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06
08175700156127Scleral DepressorsAURORA SURGICAL, LLCHNX2024-02-06