FDA.reportPublic FDA data

Bausch + Lomb

Primary DI
00757770421084
Brand
Bausch + Lomb
Company
Bausch & Lomb Incorporated
Model
E3797
Device description
NEEDLE HOLDER CURVED STORZ
Published
2024-08-26
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
HNESnare, enucleating
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNESnare, EnucleatingOphthalmic1
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00757770421084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00757770421084007577704210847577704210840757770421084

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
00757770409167Bausch + LombS2050 10SS2050 10S2016-09-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995317973V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318024V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318246V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318253V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318284V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318307V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318338V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318345V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318451V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318468V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318475V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318482V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318499V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318598V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318673V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318680V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318697V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318703V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318741V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318772V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318833V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318857V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318932V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995318949V. MuellerSTERIS Deutschland GmbHHNR2026-09-25
00724995317980V. MuellerSteris CorporationHNR2026-09-24
00724995318321V. MuellerSteris CorporationHNR2026-09-24
00724995318413V. MuellerSteris CorporationHNR2026-09-24
00724995318420V. MuellerSteris CorporationHNR2026-09-24
00724995318437V. MuellerSteris CorporationHNR2026-09-24
00724995318444V. MuellerSteris CorporationHNR2026-09-24