FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770455867
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E3097
Catalog number
E3097
Device description
PUNCH AND HANDLE SET COTTINGHA
Published
2024-11-21
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
HRHTrephine, Manual, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRHTrephine, Manual, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770455867PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770455867007577704558677577704558670757770455867

GMDN Terms#

Term, Definition table
TermDefinition
Corneoscleral punchA hand-held, manual ophthalmic surgical instrument designed to excise a segment of tissue (frequently in the form of a disc) from the sclera or cornea of a patient or from grafts taken from cadaver donors. It typically has a set of sharp, hollow tips at the distal end (a rotary mechanism that may be either integral or an attachment) operated by squeezing a two-part handle. The device is used mainly to perform ophthalmic graft implantations or, less frequently, to obtain grafts from the sclera of cadaver donors. 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
00841668146460BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146484BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146491BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146507BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146514BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146521BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146538BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146545BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146552BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146569BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146576BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146590BarronKATENA PRODUCTS, INC.HRH2026-06-10
00841668146606BarronKATENA PRODUCTS, INC.HRH2026-06-10
05055445956165SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956172SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956189SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956196SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956202SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956219SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956226SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
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05055445956257SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956264SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956271SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956288SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956295SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956301SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956318SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12
05055445956325SurtexSURTEX INSTRUMENTS LTD.HRH2026-05-12