FDA.reportPublic FDA data

Needle Halsey Smooth Angled Thumb Grip

Primary DI
05060480406278
Brand
Needle Halsey Smooth Angled Thumb Grip
Company
BLINK MEDICAL LIMITED
Model
HR527
Published
2022-06-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
05060480400733PackageGS110In Commercial Distribution
05060480406278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060480400733050604804007335060480400733
05060480406278050604804062785060480406278

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05056785303343Connor Wand41-4013BNS2026-01-26
05056785303268Cataract Instrument Pack - UCM67-00302025-12-11
05056785302704Lenticule Removal Forceps, Serrated Jaw, Direct Action11-90022025-11-14
05056785302728Lenticule Extraction Forceps, Serrated Jaw, Cross Action11-90042025-11-14
05056785302742ICL Loading Forceps, Smooth Jaw, Direct Action11-90012025-11-14
05056785302766ICL Loading Forceps, Smooth Jaw, Cross Action11-90032025-11-14
05056785303022Cataract Inst Set - Spokane Anderson67-00282025-11-12
05056785303046Cataract Inst Set - Spokane Adams67-00292025-11-12
05056785302452Bonn Forceps Straight 0.12mm Toothed, O/L 102mm10-11082025-09-19
05060480409040FORCEPS BONN STRAIGHT 0.25MM TOOTHED O/L 106MM10-1106BNS2025-09-18
05060745555314FORCEPS CAPSULORHEXIS UTRATA MICS SS ST11-5050BNS2025-09-18
05060480409538Speculum Leibinger31-30022025-09-18
05056785302605RC Kit 167-0018A2025-09-18
05056785302537RC Kit 267-0010A2025-09-03
05056785302568Stockton Kit 267-0014A2025-09-03
05056785302582Stockton Kit 167-0017A2025-09-03
05056785302476Kaiser AMD Instrument Set67-0026A2025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091124ELMED INCORPORATEDELMED INCORPORATEDGEN2026-05-26
00810220800195Adler Instrument CompanyAdler, Inc.FHQ2026-05-26
00846159039269SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039276SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039283SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039290SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039306SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039313SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039320SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039337SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039344SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039351SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039368SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039375SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039382SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039399SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039405SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039412SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039429SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039436SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039443SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039450SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039467SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039474SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039481SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039498SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039504SCANLAN® ForcepsSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039511SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039528SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26
00846159039535SCANLAN® ClampSCANLAN INTERNATIONAL INCGEN2026-05-26