AccessGUDID - DEVICE: Verisyse (08717819047981)

GUDID

Device Identifier (DI) Information

Brand Name: Verisyse
Version or Model: VRSM6US
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VRSM6US -8.0D
Company Name: Ophtec B.V.

Primary DI Number: 08717819047981
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: Verisyse Myopia 6.0 mm -8.0D

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?
47410	Anterior-chamber intraocular lens, phakic	An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the region of the eye posterior of the cornea and anterior of the iris (anterior chamber) to provide refractive correction of vision without removal of the natural lens (crystalline lens). The device is typically made of a synthetic polymer; disposable devices associated with implantation (e.g., IOL injector) may be included with the lens.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MTA	Lens, Intraocular, Phakic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P030028	001
P030028	002
P030028	003
P030028	004
P030028	005
P030028	006
P030028	008

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
Handling Environment Temperature: less than 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: -8.0 Diopter, D

Device Record Status

Public Device Record Key: 69d57faf-fd4b-4c6b-a6d3-ab1ccf4fd6b7
Public Version Date: July 08, 2021
Public Version Number: 6
DI Record Publish Date: August 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

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES