FDA.reportPublic FDA data

ASSI

Primary DI
00841645122968
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.AB56126
Device description
Breast Retractor/Dissector Spatulated 32cm, Semi-Malleable blade 190x38mm
Published
2020-06-29
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
GDIDissector, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645122968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645122968008416451229688416451229680841645122968

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. 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
07898789390015TREPSAT FACELIFT DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-23
00192896122888DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122895Ball DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122901Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122918Hook DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122925Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
00192896122932Spatula DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-19
09348811151254INKAThe Trustee for KAISER FAMILY TRUSTGDI2026-03-16
00192896122703Ochsner DissectorSONTEC INSTRUMENTS, INC.GDI2026-03-10
00840180544778General InstrumentsALPHATEC SPINE, INC.GDI2026-01-29
00840180544525General InstrumentsALPHATEC SPINE, INC.GDI2025-12-31
08809407604543DissectorHankil Tech Medical Co., Ltd.GDI2025-12-16
00196449034536Anatomic Access LLIFTyber Medical, LLCGDI2025-12-02
09348811025494INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811025500INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
09348811146663INKAThe Trustee for KAISER FAMILY TRUSTGDI2025-11-20
03662663276849Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-17
00757770701209Bausch + LombBausch & Lomb IncorporatedGDI2025-11-16
03662663267236Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267243Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
03662663267250Timberline Lateral Fusion SystemHighridge Medical, LLCGDI2025-11-16
00757770676354Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
00757770688517Bausch + LombBausch & Lomb IncorporatedGDI2025-11-14
03662663131308Disc Preparation InstrumentsHighridge Medical, LLCGDI2025-11-14
03662663192835Breckenridge ACDF SystemHighridge Medical, LLCGDI2025-11-14
00196449034529Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
00763000936440NAMEDTRONIC, INC.GDI2025-09-29
00192896122116Ball ProbeSONTEC INSTRUMENTS, INC.GDI2025-09-26
16971503601937comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28
16971503601944comknife®Beijing Bohai Kangyuan Medical Devices Co., Ltd.GDI2025-08-28