FDA.reportPublic FDA data

ASSI

Primary DI
00841645109235
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ABB1A
Device description
Approximator Clamp, For Thick Walled Arteries, W/O Frame, 0.4-1.0mm Vessel Dia.
Published
2023-06-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HRQHemostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645109235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645109235008416451092358416451092350841645109235

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
00810055250684Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250691Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250707Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055250714Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259687Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259694Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259700Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259717Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259724Surgical DesignSurgical Design, Inc.HRQ2026-05-27
00810055259731Surgical DesignSurgical Design, Inc.HRQ2026-05-27
10193489456325Medline Industries, Inc.MEDLINE INDUSTRIES, INC.HRQ2022-08-04
ESAM3800121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3800141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3805141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815121STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3815141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3826141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3827141STOMA®Storz am Mark GmbHHRQ2020-08-27
ESAM3839141STOMA®Storz am Mark GmbHHRQ2020-08-27
10381780361022Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780361039Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780361046Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-07-27
10381780385998Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-05-02
10381780024958Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780024972Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780025016Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780025061Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-04-03
10381780221739Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-03-22
10381780221753Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHRQ2018-03-22