FDA.reportPublic FDA data

Barraquer Needle Holder, Curved

Primary DI
04058935011697
Brand
Barraquer Needle Holder, Curved
Company
Bausch & Lomb GmbH
Model
E3844
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058935011697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058935011697040589350116974058935011697

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
344609518
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058935012779Fogla Trifacet SpatulaE04792025-10-24
04058935012786Fogla Pointed DissectorE04802025-10-24
04058935012809Guide ClaymanE05422025-10-24
04058935012816Hook Lens And Iris SinskeyE05452025-10-24
04058935012823Hook Lens OgawaE05692025-10-24
04058935012830Chopper Spatula NichaminE0570 N2025-10-24
04058935012847Hook Lens Manipulator LesterE05712025-10-24
04058935012854Hook Lens Insertion FenzlE05722025-10-24
04058935012861Chopper Phaco Left NagaharaE0578 L2025-10-25
04058935012878Chopper Phaco Right NagaharaE0578 R2025-10-26
04058935012885Hook Lens MaloneyE05792025-10-26
04058935012892Chopper Ambidextrous SeibelE05902025-10-26
04058935012908Hook Muscle StevensE06002025-10-26
04058935012915Manipulator Nucleus DrysdaleE06292025-10-26
04058935012922Brody Multipurpose ManipulatorE06362025-10-26
04058935012939Spatula Phaco KochE07122025-10-26
04058935012946Snapper Lens ChopperE07292025-10-26
04058935012953Spatula JohnsonE07302025-10-26
04058935012960Chopper Quick-Chop Braga MeleE07562025-10-26
04058935012977Forceps Fixation Curved MoodyE15532025-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G346EEN008Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2026-04-20
08800268430111LYNKS Frontalis SlingLynk Solutec Inc.HNM2026-03-03
G346EEN0132Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-12-17
04058935011574Osher Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011581Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011598Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011604Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011611Barraquer Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011628McPherson Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011635Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011642Cohan Needle Holder, Mini CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011659Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011666Troutman Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011673Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011680Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011703Barraquer Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011710Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011727Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011734Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011741Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011758Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011765Castroviejo Needle Holder, CurvedBausch & Lomb GmbHHNM2025-07-10
04058935011772Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011789Castroviejo Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
04058935011796Derf Needle Holder, StraightBausch & Lomb GmbHHNM2025-07-10
G346EEN010Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNM2025-07-07
G223112750WHMC0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G2231138500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNM2025-06-18
G412PH10400MR PHACOCrestpoint Management LimitedHNM2025-06-03
G412PH10410MR PHACOCrestpoint Management LimitedHNM2025-06-03