AccessGUDID - DEVICE: StabilEyes (08717819039399)

GUDID

Device Identifier (DI) Information

Brand Name: StabilEyes
Version or Model: STBL13US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: STBL13US
Company Name: Ophtec B.V.

Primary DI Number: 08717819039399
Issuing Agency: GS1
Commercial Distribution End Date: October 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 405048120 *Terms of Use

Device Description: Capsular Tension Ring 13.0 mm.

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):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
42839	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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MRJ	Ring, Endocapsular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030023	001
P030023	002
P030023	007

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
Storage Environment Temperature: between 50 and 80 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 13 Millimeter

Device Record Status

Public Device Record Key: 45f28553-ddbf-4ef1-92d9-65933e5819b7
Public Version Date: September 09, 2019
Public Version Number: 5
DI Record Publish Date: June 24, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(877)266-4543
Email: SAN-SURGICAL-ORDERS@AMO.ABBOTT.COM

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