FDA.reportPublic FDA data

ASSI

Primary DI
00841645127284
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.AG29306
Device description
Ribbon Retractor 200 x 6mm, malleable
Published
2020-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645127284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645127284008416451272848416451272840841645127284

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
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
00841536148640ThompsonThompson Surgical Instruments, Inc.GAD2026-09-20
08800322775561Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775578Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775585Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775592Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775608Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775615Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775622Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775639Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775646Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775653Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775660Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775677Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775684Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775691Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775707Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322775714Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776872Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776889Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776896Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
08800322776902Sheathe BladeGS Medical Co., Ltd.GAD2026-09-18
00190776429102MillenniumAvalign Technologies, Inc.GAD2026-09-04
00840319759400Hayden MedicalHayden Medical, Inc.GAD2026-09-04
00840319759417Hayden MedicalHayden Medical, Inc.GAD2026-09-04
04058749046076NAFehling Instruments GmbH & Co. KGGAD2026-09-04
00190776428129MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428259MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428266MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428273MillenniumAvalign Technologies, Inc.GAD2026-08-27
00190776428280MillenniumAvalign Technologies, Inc.GAD2026-08-27