FDA.report

Castroviejo Needle Holder, Curved

Primary DI
04058935011765
Brand
Castroviejo Needle Holder, Curved
Company
Bausch & Lomb GmbH
Model
E3861 WHMC
Published
2025-07-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNMNeedle, Ophthalmic Suturing

Product Code Classifications

CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04058935011765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04058935011765040589350117654058935011765

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
344609518
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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00405893501229Gills-Welsh-Vannas Capsulotomy ScissorsE3388 GW2025-07-11
04058935011086Tissue ForcepsE14002025-07-11
04058935011093Straight Dressing ForcepsE14042025-07-11
04058935011109Curved Dressing ForcepsE14062025-07-11
04058935011116Strong Curved Dressing ForcepsE14082025-07-11
04058935011123Light Curved Dressing ForcepsE14102025-07-11
04058935011130Bracken Iris ForcepsE14162025-07-11
04058935011147Straight Tissue ForcepsE14202025-07-11
04058935011154Gill Curved Iris ForcepsE14752025-07-11
04058935011161Bishop-Harmon Tissue ForcepsE15002025-07-11
04058935011178Bishop-Harmon Curved Tissue ForcepsE1500 C2025-07-11
04058935011185Bishop-Harmon Tissue ForcepE15022025-07-11
04058935011192Bishop-Harmon Dressing ForcepsE15062025-07-11
04058935011208Graefe Fixation ForcepsE15602025-07-11
04058935011215Graefe Fixation ForcepsE15722025-07-11
04058935011222Green Fixation ForcepsE16002025-07-11
04058935011239Lester Fixation ForcepsE16542025-07-11
04058935011246Lester Fixation ForcepsE16562025-07-11
04058935011253Elschnig Fixation ForcepsE16842025-07-11
04058935011260Iowa State Fixation ForcepsE17242025-07-11

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