FDA.reportPublic FDA data

ASSI

Primary DI
00841645132837
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.MTK2051220
Device description
Mayo Hegar Needle Holder 20cm, TC Jaw
Published
2020-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FHQHolder, Needle, Gastroenterologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHQHolder, Needle, GastroenterologicGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645132837PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645132837008416451328378416451328370841645132837

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
055870299
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841645131991ASSIASSI.FOC178/752020-06-30
00841645119371ASSIASSI.125262020-06-25
00841645119425ASSIASSI.129262020-06-25
00841645103325ASSIASSI.FOAL2682016-09-26
00841645131830ASSIASSI.FOAE1632016-09-26
00841645131847ASSIASSI.FOAE1642016-09-26
00841645131854ASSIASSI.FOAE1652016-09-26
00841645131861ASSIASSI.FOAHL2802016-09-26
00841645131878ASSIASSI.FOAL2602016-09-26
00841645131885ASSIASSI.FOAL2612016-09-26
00841645131892ASSIASSI.FOAL2622016-09-26
00841645131908ASSIASSI.FOAL2662016-09-26
00841645131915ASSIASSI.FOAL2672016-09-26
00841645131922ASSIASSI.FOAL2712016-09-26
00841645131939ASSIASSI.FOC158/62016-09-26
00841645131946ASSIASSI.FOC158/752016-09-26
00841645131953ASSIASSI.FOC158/982016-09-26
00841645131960ASSIASSI.FOC171/62016-09-26
00841645131977ASSIASSI.FOC171/752016-09-26
00841645131984ASSIASSI.FOC171/982016-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7370TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7380TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7390TBS BASICSACME ENTERPRISE.FHQ2026-05-21
G149TBSB7400TBS BASICSACME ENTERPRISE.FHQ2026-05-21
08961104621824Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621831Mathieu Standard TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621848Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621855Mathieu Standard Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621862Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621879Mathieu Narrow TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621886Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621893Mathieu Narrow Tip TCMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621909Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621916Mathieu Narrow Tip HalfMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621923Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621930Mathieu Hook TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621947Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621954Mathieu Hole TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621961Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621978Mathieu Hook Tip GroovedMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621985Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
08961104621992Mathieu Smaha Ultra Fine TipMELPEX BEAUTY INSTRUMENTSFHQ2026-05-21
G45313110753150PEAK MEDICALPeak Medical Distribution Inc.FHQ2026-05-06
G4254202900My MedicalMy Medical Store LLCFHQ2026-05-04
G4254203160My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209120My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209140My MedicalMy Medical Store LLCFHQ2026-05-04
G4254209170My MedicalMy Medical Store LLCFHQ2026-02-17
G45313110845130PEAK MEDICALPeak Medical Distribution Inc.FHQ2023-07-03
G25004025180Tungsten Carbide Debakey Needle Holder 18cmN S SURGICAL COMPANYFHQ2023-01-27