FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770535699
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E0816 C
Catalog number
E0816 C
Device description
PTERYGIUM BURR MEDIUM DIAMOND 3.5mm
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
00757770535699PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770535699007577705356997577705356990757770535699

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
10757770229908SoFlex® SE IOLLI61SELI61SE22002024-05-21
10757770096746PMMA (P359UV)P359UV2R0002015-09-17
10757770096760PMMA (P359UV)P359UV2R0102015-09-17
10757770096784PMMA (P359UV)P359UV2R0202015-09-17
10757770096807PMMA (P359UV)P359UV2R0302015-09-17
10757770096821PMMA (P359UV)P359UV2R0402015-09-17
10757770096845PMMA (P359UV)P359UV2R0502015-09-17
10757770096869PMMA (P359UV)P359UV2R0602015-09-17
10757770096883PMMA (P359UV)P359UV2R0702015-09-17
10757770096906PMMA (P359UV)P359UV2R0802015-09-17
10757770096920PMMA (P359UV)P359UV2R0902015-09-17
10757770096944PMMA (P359UV)P359UV2R1002015-09-17
10757770096951PMMA (P359UV)P359UV2R1052015-09-17
10757770096968PMMA (P359UV)P359UV2R1102015-09-17
10757770096975PMMA (P359UV)P359UV2R1152015-09-17
10757770096982PMMA (P359UV)P359UV2R1202015-09-17
10757770096999PMMA (P359UV)P359UV2R1252015-09-17
10757770097002PMMA (P359UV)P359UV2R1302015-09-17
10757770097019PMMA (P359UV)P359UV2R1352015-09-17
10757770097026PMMA (P359UV)P359UV2R1402015-09-17

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
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