FDA.reportPublic FDA data

ASSI

Primary DI
00841645129998
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ATK158925
Device description
Joseph Periosteal Elevator, 17cm Light Forward Cvd. 2.5mm
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
KADElevator, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KADElevator, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645129998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645129998008416451299988416451299980841645129998

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery (e.g., dental, orthopaedic), including use on the ribs. In dentistry it may be used to access retained roots, or for their removal with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
00724995270704V. MuellerSTERIS Deutschland GmbHKAD2026-09-25
00724995270759V. MuellerSTERIS Deutschland GmbHKAD2026-09-25
04054462905577evonosevonos GmbH & Co. KGKAD2026-08-21
04054462905584evonosevonos GmbH & Co. KGKAD2026-08-21
04054462905645evonosevonos GmbH & Co. KGKAD2026-08-21
04054462906512evonosevonos GmbH & Co. KGKAD2026-08-21
04054462906529evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907366evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907380evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907397evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907441evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907496evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907502evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907519evonosevonos GmbH & Co. KGKAD2026-08-21
04054462907526evonosevonos GmbH & Co. KGKAD2026-08-21
04054462911462evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911479evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911486evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911493evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911936evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911943evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911950evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911967evonosevonos GmbH & Co. KGKAD2026-08-19
04054462911998evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912001evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912018evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912032evonosevonos GmbH & Co. KGKAD2026-08-19
04054462912674evonosevonos GmbH & Co. KGKAD2026-08-19
04054462907373evonosevonos GmbH & Co. KGKAD2026-08-18
04054462907403evonosevonos GmbH & Co. KGKAD2026-08-18