FDA.reportPublic FDA data

gSource

Primary DI
M7552142880
Brand
gSource
Company
GSOURCE LLC
Model
gS 21.4288
Catalog number
gS 21.4288
Device description
Mayo Hegar NH 8" deli serr
Published
2019-11-18
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

Product Codes#

Code, Name table
CodeName
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M7552142880PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
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
008162518
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
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840314265241gSourcegS 86.9711gS 86.97112024-12-06
00840314216854gSourcegS 40.1100gS 40.11002019-12-17
00840314270276gSourcegS 33.0310gS 33.03102026-05-20
00840314270283gSourcegS 33.0311gS 33.03112026-05-20
00840314270221gSourcegS 82.7715gS 82.77152026-03-20
00840314270238gSourcegS 82.7717gS 82.77172026-03-20
00840314270245gSourcegS 86.8120gS 86.81202026-03-20
00840314270252gSourcegS 86.8125gS 86.81252026-03-20
00840314270269gSourcegS 86.8130gS 86.81302026-03-20
00840314238511gSourcegS 75.3124gS 75.31242025-11-24
00840314238528gSourcegS 75.3250gS 75.32502025-11-24
00840314238535gSourcegS 75.3280gS 75.32802025-11-24
00840314238542gSourcegS 75.9230gS 75.92302025-11-24
00840314238559gSourcegS 75.9240gS 75.92402025-11-24
00840314238566gSourcegS 75.9250gS 75.92502025-11-24
00840314238573gSourcegS 75.9255gS 75.92552025-11-24
00840314238580gSourcegS 75.9260gS 75.92602025-11-24
00840314238597gSourcegS 75.9282gS 75.92822025-11-24
00840314238603gSourcegS 75.9300gS 75.93002025-11-24
00840314238610gSourcegS 75.9302gS 75.93022025-11-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083275235Intrace USAPILOTIS TECH LLCHXK2026-07-03
00850083275594Intrace USAPILOTIS TECH LLCHXK2026-07-03
00850083275945Intrace USAPILOTIS TECH LLCHXK2026-07-03
00850083275952Intrace USAPILOTIS TECH LLCHXK2026-07-03
04052536078349neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536078356neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536078363neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536169931neon3Ulrich GmbH & Co. KGHXK2026-06-09
04052536161997neon3Ulrich GmbH & Co. KGHXK2026-06-08
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
04058749119695NAFehling Instruments GmbH & Co. KGHXK2025-12-08
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
04052536078264uCentumUlrich GmbH & Co. KGHXK2025-08-01
04052536078271uCentumUlrich GmbH & Co. KGHXK2025-08-01
04052536078295uCentumUlrich GmbH & Co. KGHXK2025-08-01
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488153Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
10649111488139Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111488160Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-22
10649111062698Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-11
10649111062957Sklar InstrumentsSKLAR CORPORATIONHXK2025-02-10
10649111063268Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31
10649111063541Sklar InstrumentsSKLAR CORPORATIONHXK2025-01-31