FDA.reportPublic FDA data

ASSI

Primary DI
00841645113065
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.SAS15R8
Device description
Adventitia Sciss., 15cm Lg. Rnd. Hdl. 8mm Dia., Str. Bl. 9mm
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LRWScissors, General, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645113065PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645113065008416451130658416451130650841645113065

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. 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
G425050183SCD0My MedicalMy Medical Store LLCLRW2026-05-04
G425050933SC0My MedicalMy Medical Store LLCLRW2026-03-27
09348811003119INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-03-18
09348811000798INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000804INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000842INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000859INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811000866INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811153494INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
09348811173058INKAThe Trustee for KAISER FAMILY TRUSTLRW2026-02-12
10198956213302CARDINAL HEALTHCardinal Health 200, LLCLRW2025-11-24
09348811000811INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001313INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811001702INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811002433INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003171INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811003805INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
09348811007117INKAThe Trustee for KAISER FAMILY TRUSTLRW2025-11-19
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G453CA455660PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21
G453CA463680PEAK MEDICALPeak Medical Distribution Inc.LRW2025-10-21