FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770418640
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
N5345 G
Catalog number
N5345 G
Device description
GUARD ONLY FOR N5345 AND N5346
Published
2025-08-18
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
LXZGuard, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXZGuard, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770418640PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770418640007577704186407577704186400757770418640

GMDN Terms#

Term, Definition table
TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
04262488440044TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440037TissueGUARDTissueGUARD GmbHLXZ2025-04-25
04262488440020TissueGUARDTissueGUARD GmbHLXZ2025-04-24
04262488440013TissueGUARDTissueGUARD GmbHLXZ2025-04-24
10843356102694CYGNUSCYGNUS MEDICAL L.L.C.LXZ2024-12-11
00822409101160N/AOrtho Development CorporationLXZ2023-10-06
B7689188290Buxton BioMedicalBuxton Biomedical IncLXZ2023-07-07
00822409104031n/aOrtho Development CorporationLXZ2022-05-01
00847399007186MicroAire® Microaire Surgical Instruments LLCLXZ2022-03-30
00847399000798MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399000804MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399003690MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-30
00847399007001MicroAire® Microaire Surgical Instruments LLCLXZ2021-12-29
107073877920053M™ Attest™3M COMPANYLXZ2021-06-18
107073877920123M™ Attest™3M COMPANYLXZ2021-06-18
107073877920293M™ Attest™3M COMPANYLXZ2021-06-18
307073874694443M™ Comply™3M COMPANYLXZ2021-06-18
307073874694513M™ Comply™3M COMPANYLXZ2021-06-18
307073874694683M™ Comply™3M COMPANYLXZ2021-06-18
507073877920033M™ Attest™3M COMPANYLXZ2021-06-18
507073877920103M™ Attest™3M COMPANYLXZ2021-06-18
507073877920273M™ Attest™3M COMPANYLXZ2021-06-18
507073874694483M™ Comply™3M COMPANYLXZ2021-06-18
507073874694553M™ Comply™3M COMPANYLXZ2021-06-18
507073874694623M™ Comply™3M COMPANYLXZ2021-06-18
10884527010219DevonCardinal Health, Inc.LXZ2018-06-23