AccessGUDID - DEVICE: SOFTEC I (00844369029742)

GUDID

Device Identifier (DI) Information

Brand Name: SOFTEC I
Version or Model: SOFTECI+29.0
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SOFTEC I
Company Name: Lenstec Barbados Inc

Primary DI Number: 00844369029742
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 860235001 *Terms of Use

Device Description: IOL - HEMA - 1pc 5.75/12.0mm

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?
35658	Posterior-chamber intraocular lens, pseudophakic	An optical device, generally referred to as an intraocular lens (IOL), intended to be implanted permanently in the posterior chamber of the eye (ring-like space filled with aqueous humor between the iris, the crystalline lens, and the ciliary body) to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. The device is made of a synthetic material (e.g., plastic, hydrogel). Included may be a sterile, single-use, IOL injector into which this device is preloaded and ready for insertion into the eye. 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
HQL	Intraocular Lens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P090022	001

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 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Overall Length, 12.0mm
Device Size Text, specify: Optic Diameter, 5.75mm

Device Record Status

Public Device Record Key: b330764a-4aba-4c7e-972b-918ee325edec
Public Version Date: July 08, 2021
Public Version Number: 4
DI Record Publish Date: August 01, 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: Yes
Serial Number: Yes
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 1-866-536-7832
Email: feedback@lenstec.com

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