FDA.reportPublic FDA data

ASSI

Primary DI
00841645130369
Brand
ASSI
Company
ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORPORATION
Model
ASSI.ATK2409405
Device description
Lambotte Osteotome 17cm, 5mm blade
Published
2020-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HNRForceps, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841645130369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841645130369008416451303698416451303690841645130369

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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
G006D50190300Tuebingen Model Tying forceps strDAUD JEE MFG. COHNR2023-01-05
G006D50190400Tuebingen Model Tying forceps cvdDAUD JEE MFG. COHNR2023-01-05
G006D5052200TENNAT TYING FORCEPS STR DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052300TENNAT TYING FORCEPS CVD DEL 6MM LONGDAUD JEE MFG. COHNR2023-01-05
G006D5052340MAUMENEE TYING FORCEPS STRDAUD JEE MFG. COHNR2023-01-05
G006D5052350MAUMENEE TYING FORCEPS ANGDAUD JEE MFG. COHNR2023-01-05
G006D5054000HARMS TYING FORCEPS STR STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5054100HARMS TYING FORCEPS CVD STANDARDDAUD JEE MFG. COHNR2023-01-05
G006D5051120ANIS TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-21
G006D5051130ANIS TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-21
G006D5051900FREEMAN-JAFFE LENS HOLDING FORCEPSDAUD JEE MFG. COHNR2022-12-21
G006D5052000JAFFE TYING FORCEPS STRAIGHT DAUD JEE MFG. COHNR2022-12-21
G006D5052100JAFFE TYING FORCEPS CURVED DAUD JEE MFG. COHNR2022-12-21
G006D5051000SINSKEY TYING FORCEPS STR DELDAUD JEE MFG. COHNR2022-12-20
G006D5051100SINSKEY TYING FORCEPS CVD DELDAUD JEE MFG. COHNR2022-12-20
G006D35072330AKAHOSHI SUPER COMBO III PRECHOPPERDAUD JEE MFG. COHNR2022-12-19
G006D50313000Capsulorhexis Forceps G PATTERNDAUD JEE MFG. COHNR2022-12-19
G006D504050810 CAPS FORCEPS RND HDL STR DAUD JEE MFG. COHNR2022-12-19
G006D505000910CAPSULORRHEXIS FORCEPS ROUND HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D505000990CAPSULORRHEXIS FORCEPS FOR MICRO COXIAL 2MMDAUD JEE MFG. COHNR2022-12-19
G006D506000000CAPSULORRHEXIS FORCEPS FOR MICS/MCCSDAUD JEE MFG. COHNR2022-12-19
G006D506000020CAPSULORRHEXIS FORCEPS 12MMDAUD JEE MFG. COHNR2022-12-19
G006D506000030CAPSULORRHEXIS FORCEPS 11MMDAUD JEE MFG. COHNR2022-12-19
G006D5060000510PRECHOPPER COMBO CROSS SECTION SHARP TIPDAUD JEE MFG. COHNR2022-12-19
G006D507000030CAPSULORRHEXIS FORCEPS 11MM ANGLEDDAUD JEE MFG. COHNR2022-12-19
G006D50800012340TITANIUM CAPSULORRHEXIS FORCEPS ERGONOMIC HANDLEDAUD JEE MFG. COHNR2022-12-19
G006D508000123410TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 12MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123420TITANIUM CAPSULORRHEXIS FORCEPS ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D508000123430TITANIUM CAPSULORRHEXIS FORCEPS STRONG ANGLED 11MMDAUD JEE MFG. COHNR2022-12-19
G006D50171630CORYDON FORCEPS EROGONOMIC ROUND HANDLEDAUD JEE MFG. COHNR2022-12-17