FDA.reportPublic FDA data

ASSI

Primary DI
00841645109877
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ATCC10
Device description
Approximator Dbl. Tube Clamp W/ Suture Holding Frame, 5.0mm
Published
2023-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FFNClamp, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FFNClamp, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645109877PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645109877008416451098778416451098770841645109877

GMDN Terms#

Term, Definition table
TermDefinition
Vessel approximatorOne of a pair or set of surgical instruments used to grasp the torn or resected portions of a vessel to hold the portions in apposition for the purpose of reattaching one portion to the other in order to repair the structure. The instrument is also used to grasp a vessel, or separated parts of a vessel, to position it in a surgical opening. 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
00190776418472MillenniumAvalign Technologies, Inc.FFN2026-03-25
00190776415747MillenniumAvalign Technologies, Inc.FFN2026-02-04
00840183530341BR Surgical, LLCBR Surgical, LLCFFN2025-09-05
04049047072898GimmiGimmi GmbHFFN2025-04-02
00840183526979BR Surgical, LLCBR Surgical, LLCFFN2024-05-30
00888515048317BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515048324BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515048362BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00888515326705BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.FFN2024-02-28
00190776305512MillenniumAvalign Technologies, Inc.FFN2023-11-16
00190776248321AvalignAvalign Technologies, Inc.FFN2023-09-28
00190776248826AvalignAvalign Technologies, Inc.FFN2023-09-28
00190776293840MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00190776329297MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00190776329303MILLENNIUMAvalign Technologies, Inc.FFN2023-09-28
00841645112396ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645112419ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645141952ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645142447ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645142706ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-08-11
00841645103332ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109884ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109891ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109907ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109914ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109921ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109938ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109945ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109952ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109969ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27