FDA.reportPublic FDA data

ASSI

Primary DI
00841645112013
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.HDDVB
Device description
Hand Applied Approximator Clamp 1.5 - 3.5mm Vessel Dia. Black
Published
2023-06-29
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
00841645112013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645112013008416451120138416451120130841645112013

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
00810143909197SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909265SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909302SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143909616SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931777SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931784SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931791SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931807SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931814SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931906SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931920SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931937SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931944SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931951SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212931968SURGIPROSSurgipros, LLCHRQ2026-07-31
00810212935089SURGIPROSSurgipros, LLCHRQ2026-07-31
00810143907438SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908725SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908732SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908749SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143908756SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909722SURGIPROSSurgipros, LLCHRQ2026-07-30
00810143909739SURGIPROSSurgipros, LLCHRQ2026-07-30
00840183532321BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00840183533076BR Surgical, LLCBR Surgical, LLCHRQ2026-07-20
00810055258567Surgical DesignSurgical Design, Inc.HRQ2026-06-22
00810055258574Surgical DesignSurgical Design, Inc.HRQ2026-06-22
05060212051103Crile Artery Forceps, 145mm StraightDTR MEDICAL LIMITEDHRQ2026-06-10
05060212051110Crile Artery Forceps, 145mm Curved on FlatDTR MEDICAL LIMITEDHRQ2026-06-10
05060411984639Baby Overholt Artery Forceps Curved, 140mmDTR MEDICAL LIMITEDHRQ2026-06-10