FDA.reportPublic FDA data

ASSI

Primary DI
00841645109778
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ACC55VB
Device description
Approximator Clamp, without frame; for veins Black
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
HRQHemostat

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRQHemostatGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645109778PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645109778008416451097788416451097780841645109778

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
00810055259663Surgical DesignSurgical Design, Inc.HRQ2026-05-26
00810055259670Surgical DesignSurgical Design, Inc.HRQ2026-05-26
00810143907490SURGIPROSSurgipros, LLCHRQ2026-05-23
00810212933054SURGIPROSSurgipros, LLCHRQ2026-05-22
04059453072740Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2026-01-13
04059453072788Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2026-01-13
00810207781929Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781936Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781943Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781950Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781967Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781974Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781981Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207781998Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782001Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782018Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782025Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782032Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782049Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782056Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782063Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782117Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00810207782124Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRQ2025-11-24
00840183531133BR Surgical, LLCBR Surgical, LLCHRQ2025-09-29
05010058178885InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-09-11
05010058182554InstrapacROBINSON HEALTHCARE LIMITEDHRQ2025-09-11
04059453071279Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRQ2025-09-09
00840183530631BR Surgical, LLCBR Surgical, LLCHRQ2025-08-22
00840183529567BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16
00840183529574BR Surgical, LLCBR Surgical, LLCHRQ2025-07-16