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
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
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