FDA.reportPublic FDA data

Needle Holder Nieverts 13cm

Primary DI
05060480406254
Brand
Needle Holder Nieverts 13cm
Company
BLINK MEDICAL LIMITED
Model
HR523
Published
2022-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic
GENForceps, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060480400719PackageGS110In Commercial Distribution
05060480406254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060480400719050604804007195060480400719
05060480406254050604804062545060480406254

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, single-useA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It has short serrated jaws at the distal end to provide better grip of the needle, and 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. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
738288096
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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05056785303350Double Ended Y and ICL Shaped Manipulator41-90152026-02-04
05056785302988Kratz Plastic Mechanical Speculum31-30052026-02-04
05056785303008Plastic Solid Bladed Mechanical Speculum31-30062026-02-04
05056785303367Double Ended Y and ICL Shaped Manipulator41-90152026-02-04
05056785302445Bonn Forceps Straight 0.12mm Toothed, O/L 106mm10-11082025-09-19
05056785303336Connor Wand41-4013BNS2026-01-26
05056785303343Connor Wand41-4013BNS2026-01-26
05056785303251Cataract Instrument Pack - UCM67-00302025-12-11
05056785303268Cataract Instrument Pack - UCM67-00302025-12-11
05056785302698Lenticule Removal Forceps, Serrated Jaw, Direct Action11-90022025-11-14
05056785302711Lenticule Extraction Forceps, Serrated Jaw, Cross Action11-90042025-11-14
05056785302735ICL Loading Forceps, Smooth Jaw, Direct Action11-90012025-11-14
05056785302759ICL Loading Forceps, Smooth Jaw, Cross Action11-90032025-11-14
05056785303015Cataract Inst Set - Spokane Anderson67-00282025-11-12
05056785303039Cataract Inst Set - Spokane Adams67-00292025-11-12
05056785302704Lenticule Removal Forceps, Serrated Jaw, Direct Action11-90022025-11-14

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