FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770418244
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E3316
Catalog number
E3316
Device description
SCS CONJ STORZ WESTCOT WD MINI
Published
2024-11-25
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
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770418244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770418244007577704182447577704182440757770418244

GMDN Terms#

Term, Definition table
TermDefinition
Conjunctival scissors, reusableA hand-held, manual, ophthalmic surgical instrument intended to be used to cut the conjunctiva and Tenon’s capsule on the eye surface to access the sclera. It comprises two pivoted blades which cut with a shearing action directly adjacent to the handles (thumb ring-handles or tweezers-like handles). It is typically made of metal and is available in various designs and sizes. It may additionally be used for cutting sutures and/or drapes, however, it is neither intended for intraocular surgery nor for other extraocular surgeries. 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
00190776439828MilleniumAvalign Technologies, Inc.HNF2026-10-28
B382SD9039901000Surgical DirectSurgical Direct, Inc.HNF2026-10-28
G346ED1010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-10-28
00724995315870V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995315894V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995316518V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995316570V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995316693V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
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00724995316716V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316723V. MuellerSTERIS Deutschland GmbHHNF2026-10-27
00724995316730V. MuellerSTERIS Deutschland GmbHHNF2026-10-27