AccessGUDID - DEVICE: EYEJET® CTR (04048509392079)

GUDID

Device Identifier (DI) Information

Brand Name: EYEJET® CTR
Version or Model: 15B RIGHT V.1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Morcher GmbH

Primary DI Number: 04048509392079
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327283586 *Terms of Use

Device Description: SINGLE-USE PRE-LOADED CAPSULAR TENSION RING

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Capsular tension ring	A 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.

GMDN Preferred Term Name

GMDN Definition

Capsular tension ring

A 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.

FDA Product Code

[?]

Product Code	Product Code Name
MRJ	Ring, Endocapsular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P010059	004

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store horizontally at room temperature!, Keep dry, Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aa975f7c-43d1-48d1-95cd-c907fe4a433c
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 31, 2014