FDA.reportPublic FDA data

ASSI

Primary DI
00841645109952
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ATCC55
Device description
Approximator Dbl. Tube Clamp W/Out Suture Holding Frame, 2.5MM
Published
2023-06-27
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
FFNClamp, Non-Electrical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645109952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645109952008416451099528416451099520841645109952

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
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
00841645143215ASSIASSI.BPNS243252023-08-18
00841645143222ASSIASSI.BPNS153392023-08-18
00841645142843ASSIASSI.SU632262023-08-11
00841645104988ASSIASSI.ACC1VB2023-08-11
00841645105091ASSIASSI.R1A2023-08-11
00841645105107ASSIASSI.ACC11AB2023-08-11
00841645105176ASSIASSI.DC1VB2023-08-11
00841645107385ASSIASSI.BS18822023-08-11
00841645108412ASSIASSI.005822023-08-11
00841645108474ASSIASSI.158842023-08-11
00841645108498ASSIASSI.16252023-08-11
00841645108542ASSIASSI.16632023-08-11
00841645108573ASSIASSI.16672023-08-11
00841645108634ASSIASSI.17002023-08-11
00841645108665ASSIASSI.17342023-08-11
00841645108696ASSIASSI.17402023-08-11
00841645108733ASSIASSI.17682023-08-11
00841645108771ASSIASSI.18002023-08-11
00841645108795ASSIASSI.18022023-08-11
00841645108856ASSIASSI.18322023-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00841645109877ASSIACCURATE 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
00841645109969ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27
00841645109976ASSIACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATIONFFN2023-06-27