FDA.reportPublic FDA data

ASSI

Primary DI
00841645130000
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ATK158935
Device description
Joseph Periosteal Elevator, 17cm Light Forward Cvd., 3.5mm
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
00841645130000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645130000008416451300008416451300000841645130000

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
00757770683567Bausch + LombBausch & Lomb IncorporatedKAD2026-05-11
09348811101655INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811102522INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-04-24
09348811101433INKAThe Trustee for KAISER FAMILY TRUSTKAD2026-03-18
04046826112790MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAD2026-03-04
00190776415945MillenniumAvalign Technologies, Inc.KAD2026-02-06
00757770425143Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
00757770636822Bausch + LombBausch & Lomb IncorporatedKAD2025-12-11
09348811101587INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-28
00810207783039Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783046Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783053Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783060Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783077Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783084Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783091Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783107Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783114Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783121Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783138Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783145Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
00810207783152Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDKAD2025-11-24
09348811101501INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
09348811101532INKAThe Trustee for KAISER FAMILY TRUSTKAD2025-11-24
00757770636341Bausch + LombBausch & Lomb IncorporatedKAD2025-11-15
04250381888438Hurd elevator/retractorSpiggle & Theis Medizintechnik GmbHKAD2025-10-06
04250676733900Sewall antrum elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-10-05
04250381860588Weber elevator, double endedSpiggle & Theis Medizintechnik GmbHKAD2025-09-25
04250381852057Williger elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-09-24
04250676714497Langenbeck-Quervain elevatorSpiggle & Theis Medizintechnik GmbHKAD2025-09-24