FDA.reportPublic FDA data

Artisential Needle Holder

Primary DI
08800042702960
Brand
Artisential Needle Holder
Company
LIVSMED
Model
5ANH01-FV
Device description
This device is a sterile, single-use instrument intended to hold suture needles and suture tissues.
Published
2026-04-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800042702960PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800042702960088000427029608800042702960

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter5Millimeter
Shaft Length380Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature1 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
833-548-7633infousa@livsmed.com

Regulatory Flags#

DUNS number
688360116
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
08800042706166Artisential Clip Applier LargeACA03-PG2026-07-10
08800042706173Artisential Clip Applier LargeACA03S-PG2026-07-10
08800042706111Artisential Clip Applier LargeACA03-LV2026-06-05
08800042706128Artisential Clip Applier LargeACA03-FV2026-06-05
08800042706135Artisential Clip Applier LargeACA03S-LV2026-06-05
08800042706142Artisential Clip Applier LargeACA03S-FV2026-06-05
08800042706159Artisential Monopolar SpatulaAMT01L-LH2026-06-05
08809756910067Artisential Monopolar SpatulaAMT01L-LH2026-04-28
08809756910081Artisential Clip Applier LargeACA03-FV2026-04-21
08809756910104Artisential Clip Applier LargeACA03S-FV2026-04-21
08809756910074Artisential Clip Applier LargeACA03-LV2025-09-08
08809756910098Artisential Clip Applier LargeACA03S-LV2025-09-08
08800042700355Artisential Bipolar Fenestrated ForcepsABF01L-L2026-04-30
08800042700362Artisential Bipolar Fenestrated ForcepsABF01L-F2026-04-30
08800042700454Artisential Bipolar Maryland DissectorABD01L-L2026-04-30
08800042700461Artisential Bipolar Maryland DissectorABD01L-F2026-04-30
08800042700973Artisential Bipolar Precise DissectorABD02L-L2026-04-30
08800042700980Artisential Bipolar Precise DissectorABD02L-F2026-04-30
08800042701185Artisential Bipolar Fenestrated ForcepsABF01-FV2026-04-30
08800042701192Artisential Bipolar Fenestrated ForcepsABF01S-FV2026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776435080MillenniumAvalign Technologies, Inc.MDM2026-10-15
00840456225332JMUJMU DENTAL, INCMDM2026-10-13
00840456225349JMUJMU DENTAL, INCMDM2026-10-13
06955045515634hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
06955045515689hoboatJiangsu Hope Biomedical Science&Technology Co.,Ltd.MDM2026-10-13
00190776434120MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776434229MillenniumAvalign Technologies, Inc.MDM2026-10-09
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27