FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770460083
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E0815 1.0
Catalog number
E0815 1.0
Device description
BURR/CHUCK REPLACE 1.0MM
Published
2026-04-29
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
HOFBurr, Corneal, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOFBurr, Corneal, ManualOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770460083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770460083007577704600837577704600830757770460083

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic curette, reusableA hand-held, manual, ophthalmic surgical instrument typically with a fenestrated, spoon-shaped or ring-like tip which can be either sharp or blunt, intended to be used to obtain or remove eye tissue through a scraping action. It is typically made of metal. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00757770419135Bausch + LombSP7-100344SP7-1003442026-05-11
00757770434268Bausch + LombSP7-100346SP7-1003462026-05-11
00757770652983Bausch + LombSP7-65819SP7-658192026-05-11
00757770683543Bausch + LombSP7-60918SP7-609182026-05-11
00757770683567Bausch + LombSP7-35672SP7-356722026-05-11
00757770688548Bausch + LombSP7-74835SP7-748352026-05-11
00757770714643Bausch + LombSP7-04989SP7-049892026-05-11
00757770714759Bausch + LombSP7-58985SP7-589852026-05-11
10757770529206Bausch + LombBL3124BL31242026-04-30
20757770455878Bausch + LombE3671E36712026-04-30
20757770457445Bausch + LombMVS 1022MVS 10222026-04-30
20757770457568Bausch + LombN0522 DN0522 D2026-04-30
20757770457650Bausch + LombN2398 3N2398 32026-04-30
20757770457667Bausch + LombN2398 4N2398 42026-04-30
20757770457674Bausch + LombN2398 5N2398 52026-04-30
20757770457759Bausch + LombN4847N48472026-04-30
20757770457766Bausch + LombN6305 7N6305 72026-04-30
20757770457773Bausch + LombN6305 8N6305 82026-04-30
20757770457780Bausch + LombN6305 9N6305 92026-04-30
20757770457803Bausch + LombN6372 7N6372 72026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00757770460052Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770460069Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770460076Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770535699Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770460045Bausch + LombBausch & Lomb IncorporatedHOF2024-08-26
00810799031419Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031426Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031433Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031440Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031457Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031464Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031471Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00810799031488Stephens InstrumentsKRISHNA IMPORTS INCHOF2020-09-22
00841668101247SpudKATENA PRODUCTS, INC.HOF2020-09-14
00840159903193RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903209RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903216RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903223RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903346RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159903353RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159905524RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09
00840159907818RumexRUMEX INTERNATIONAL CORP.HOF2020-06-09