FDA.reportPublic FDA data

ASSI

Primary DI
00841645129547
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.AG86726
Device description
Cushing Dura Hook 14 cm
Published
2020-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645129547PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645129547008416451295478416451295470841645129547

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue surgical hook, reusableA hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct) to allow surgical intervention on those tissues. It is not primarily designed for pulling aside tissues for surgical access purposes (i.e., not a retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. 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
00724995275082V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275099V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275105V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275112V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995275129V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293581V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293598V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293604V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995293611V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306281V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306298V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00724995306304V. MuellerSTERIS Deutschland GmbHGZX2026-09-25
00190776424121MillenniumAvalign Technologies, Inc.GZX2026-08-27
00190776420376MillenniumAvalign Technologies, Inc.GZX2026-08-25
00190776419134MillenniumAvalign Technologies, Inc.GZX2026-08-23
00190776427191MillenniumAvalign Technologies, Inc.GZX2026-08-21
00190776414672MillenniumAvalign Technologies, Inc.GZX2026-08-18
00190776408640MillenniumAvalign Technologies, Inc.GZX2026-08-03
00190776407407MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407414MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776422271MillenniumAvalign Technologies, Inc.GZX2026-07-31
00190776407322MillenniumAvalign Technologies, Inc.GZX2026-07-28
00190776404093MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404116MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404123MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404130MillenniumAvalign Technologies, Inc.GZX2026-07-24
00190776404086MillenniumAvalign Technologies, Inc.GZX2026-07-22
00190776400613MillenniumAvalign Technologies, Inc.GZX2026-07-21
00190776403386MillenniumAvalign Technologies, Inc.GZX2026-07-21
00650551006978PMT® SUCTION INSTRUMENTSPMT CORPORATIONGZX2026-07-20