FDA.reportPublic FDA data

EYEJET® CTR

Primary DI
04048509392079
Brand
EYEJET® CTR
Company
Morcher GmbH
Model
15B RIGHT V.1
Device description
SINGLE-USE PRE-LOADED CAPSULAR TENSION RING
Published
2014-10-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MRJRing, Endocapsular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRJRing, EndocapsularUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P010059004

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010059004MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14CMorcher GmbH2003-10-23MRJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048509392079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048509392079040485093920794048509392079

GMDN Terms#

Term, Definition table
TermDefinition
Capsular tension ringA sterile, open-ended, non-optical circular band intended to be used to enhance the mechanical stability of a subluxated crystalline lens capsule in the presence of weak or absent supporting zonules. The device, commonly known as a capsular tension ring (CTR) or an endocapsular ring, is permanently implanted in the crystalline lens capsular bag during intraocular lens (IOL) surgery (e.g., cataract extraction) where it produces tension to distend the bag. It is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)]. Disposable devices associated with implantation (e.g., inserter) may be included.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store horizontally at room temperature!, Keep dry, Keep away from sunlight.

Regulatory Flags#

DUNS number
327283586
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04048509620004EYEJET® CTR Type 20C Right20C RIGHT V.12023-09-14
04048509391881NA1G V.22014-10-31
04048509391898NA1L V.12014-10-31
04048509391904NA2C V.12014-10-31
04048509391911NA2L V.12014-10-31
04048509391928NA2S V.32014-10-31
04048509391935NA6D V.12014-10-31
04048509391942NA6E V.12014-10-31
04048509391959NA10C V.12014-10-31
04048509391966NA14 V.32014-10-31
04048509391973NA14A V.12014-10-31
04048509391980NA14C V.32014-10-31
04048509391997EYEJET® CTR10C RIGHT V.12014-10-31
04048509392000EYEJET® CTR10G RIGHT V.42014-10-31
04048509392017EYEJET® CTR10L RIGHT V.12014-10-31
04048509392024EYEJET® CTR14 RIGHT V.32014-10-31
04048509392031EYEJET® CTR14A RIGHT V.12014-10-31
04048509392048EYEJET® CTR14C RIGHT V.32014-10-31
04048509392055EYEJET® CTR15 RIGHT V.22014-10-31
04048509392062EYEJET® CTR15A RIGHT V.12014-10-31

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
08717819049176Artisan/ArtiflexOphtec 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