FDA.reportPublic FDA data

Artisan/Artiflex

Primary DI
08717819049176
Brand
Artisan/Artiflex
Company
Ophtec B.V.
Model
OD125A
Catalog number
OD125A
Device description
Enclavation Needles
Published
2018-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MRJRing, Endocapsular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRJRing, EndocapsularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030471000OPHTEC ENCLAVATION NEEDLEOphtec, USA2003-04-17HNQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08717819049176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08717819049176087178190491768717819049176

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, single-useA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation/implantation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Shelf-packs should be stored in a dry, climate-controlled environment

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+31505251944info@ophtec.com

Regulatory Flags#

DUNS number
405048120
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717819060126Artisan204US1W204US1W10N2015-08-25
08717819060133Artisan204US1W204US1W11N2015-08-25
08717819060140Artisan204US1W204US1W12N2015-08-25
08717819060157Artisan204US1W204US1W13N2015-08-25
08717819060164Artisan204US1W204US1W14N2015-08-25
08717819060171Artisan204US1W204US1W15N2015-08-25
08717819060188Artisan204US1W204US1W16N2015-08-25
08717819060195Artisan204US1W204US1W17N2015-08-25
08717819060201Artisan204US1W204US1W18N2015-08-25
08717819060218Artisan204US1W204US1W19N2015-08-25
08717819060225Artisan204US1W204US1W20N2015-08-25
08717819060232Artisan204US1W204US1W21N2015-08-25
08717819060249Artisan204US1W204US1W22N2015-08-25
08717819060256Artisan204US1W204US1W23N2015-08-25
08717819060263Artisan204US1W204US1W24N2015-08-25
08717819060270Artisan204US1W204US1W25N2015-08-25
08717819060287Artisan204US1W204US1W26N2015-08-25
08717819060294Artisan204US1W204US1W27N2015-08-25
08717819060300Artisan204US1W204US1W28N2015-08-25
08717819060317Artisan204US1W204US1W29N2015-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048509620004EYEJET® CTR Type 20C RightMorcher GmbHMRJ2023-09-14
08717819029789Capsular Tension RingOphtec B.V.MRJ2018-09-24
08717819090222Capsular Tension RingOphtec B.V.MRJ2018-09-24
08717819070279RingJectOphtec B.V.MRJ2016-10-07
08717819070286RingJectOphtec B.V.MRJ2016-10-07
08717819039375StabilEyesOphtec B.V.MRJ2015-06-24
08717819039399StabilEyesOphtec B.V.MRJ2015-06-24
04048509392086EYEJET® CTRMorcher GmbHMRJ2014-11-18
04048509392093EYEJET® CTRMorcher GmbHMRJ2014-11-18
04048509392109EYEJET® CTRMorcher GmbHMRJ2014-11-18
04048509391881NAMorcher GmbHMRJ2014-10-31
04048509391898NAMorcher GmbHMRJ2014-10-31
04048509391904NAMorcher GmbHMRJ2014-10-31
04048509391911NAMorcher GmbHMRJ2014-10-31
04048509391928NAMorcher GmbHMRJ2014-10-31
04048509391935NAMorcher GmbHMRJ2014-10-31
04048509391942NAMorcher GmbHMRJ2014-10-31
04048509391959NAMorcher GmbHMRJ2014-10-31
04048509391966NAMorcher GmbHMRJ2014-10-31
04048509391973NAMorcher GmbHMRJ2014-10-31
04048509391980NAMorcher GmbHMRJ2014-10-31
04048509391997EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392000EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392017EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392024EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392031EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392048EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392055EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392062EYEJET® CTRMorcher GmbHMRJ2014-10-31
04048509392079EYEJET® CTRMorcher GmbHMRJ2014-10-31