FDA.reportPublic FDA data

ASSI

Primary DI
00841645108337
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.SDC11T
Device description
Dissecting Scissors 11cm, Flat Hdl. 8mm Wide, Cvd. Serr. Blds. 15mm Lg.
Published
2023-08-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645108337PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645108337008416451083378416451083370841645108337

GMDN Terms#

Term, Definition table
TermDefinition
Vascular scissorsA hand-held, manual surgical instrument designed to cut a blood vessel (i.e., to cut over a blood vessel or cut longitudinally to split it open) during open vascular surgery; it is not intended for endoscopic use. Often referred to as micro-scissors, it is a metallic device with two small pivoted blades which cut with a shearing action. The blades are often pointed to penetrate the vessel wall, may be straight, curved sideways, or acutely angled, and may include carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

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
G04320061G0GEIZBear-Ent, LLCHNR2026-05-26
G04320062G0GEIZBear-Ent, LLCHNR2026-05-26
G04320065G0GEIZBear-Ent, LLCHNR2026-05-26
G04320067G0GEIZBear-Ent, LLCHNR2026-05-26
G04320068G0GEIZBear-Ent, LLCHNR2026-05-26
00041533986522Bruder KarpeckiThe Hilsinger Company Parent, LlcHNR2026-05-22
04251047910340Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047910357Castroviejo Suturing ForcepsA1 Medical GmbHHNR2026-05-22
04251047911552Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047911675Utrata Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047913990Kelman-McPherson Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047917905McPherson Needle HolderA1 Medical GmbHHNR2026-05-22
04251047918261Castroviejo Needle HolderA1 Medical GmbHHNR2026-05-22
04251047919336Jakobi Needle HolderA1 Medical GmbHHNR2026-05-22
04251047925252Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047925399Ergo Grip Faulkner Lens Holding ForcepsA1 Medical GmbHHNR2026-05-22
04251047925658Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047928383Ergo Grip Tennant Tying ForcepsA1 Medical GmbHHNR2026-05-22
04251047931581Ergo Grip Barraquer Needle HolderA1 Medical GmbHHNR2026-05-22
04251047932250Micro Gripping ForcepsA1 Medical GmbHHNR2026-05-22
04251047932281ILM ForcepsA1 Medical GmbHHNR2026-05-22
04251047933165SIGNUM LEHNER MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933172SIGNUM GIANETTI MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047933189SIGNUM INAMURA MICS ForcepsA1 Medical GmbHHNR2026-05-22
04251047934407Alio MICS Capsulorhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047934711Gerten DMEK Rhexis ForcepsA1 Medical GmbHHNR2026-05-22
04251047936418Gerten Iridectomy ForcepsA1 Medical GmbHHNR2026-05-22
24026704941661PILLINGTELEFLEX INCORPORATEDHNR2026-03-23
G346EA0323SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNR2026-03-12
00840319758854Hayden MedicalHayden Medical, Inc.HNR2026-03-06