FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770460045
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E0813
Device description
PTERYGIUM DIAMOND BURR 5.5MM
Published
2024-08-26
Public version status
Update
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
00757770460045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770460045007577704600457577704600450757770460045

GMDN Terms#

Term, Definition table
TermDefinition
Corneal bur manual instrumentA hand-held, ophthalmic surgical instrument that consists of a shaft with fluting or cutting planes of steel, or other hard metal, of various shapes at its distal end, used to excavate corneal tissue (e.g., removal of rust rings) through manual rotation. This is a one-piece instrument with no exchangeable components. 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
00757770460083Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
00757770535699Bausch + LombBausch & Lomb IncorporatedHOF2026-04-29
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