FDA.reportPublic FDA data

EYEJET® CTR Type 20C Right

Primary DI
04048509620004
Brand
EYEJET® CTR Type 20C Right
Company
Morcher GmbH
Model
20C RIGHT V.1
Device description
SINGLE-USE PRE-LOADED CAPSULAR TENSION RING
Published
2023-09-14
Public version status
New
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
P010059007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P010059007MORCHER CAPSULAR TENSION RING, TYPES 14, 14A AND 14CMorcher GmbH2003-10-23MRJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048509620004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048509620004040485096200044048509620004

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
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
04048509392079EYEJET® CTR15B RIGHT V.12014-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04048509392079EYEJET® CTRMorcher GmbHMRJ2014-10-31