AccessGUDID - DEVICE: IC-8 Apthera IOL (00813359020922)

GUDID

Device Identifier (DI) Information

Brand Name: IC-8 Apthera IOL
Version or Model: +19.5 D
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82078-195
Company Name: Bausch & Lomb Incorporated

Primary DI Number: 00813359020922
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196603781 *Terms of Use

Device Description: One-piece UV blocking, hydrophobic acrylic small aperture intraocular lens.

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
61210	Posterior-chamber intraocular lens, pseudophakic, extended-focus	A sterile optical device intended to be implanted into the posterior chamber of the eye to replace the natural lens (crystalline lens), typically because it has been clouded by a cataract. It consists of an intraocular lens (IOL) containing a small aperture inlay device designed to provide extended depth of focus for near vision, achieved through the pinhole effect. The components are typically made of 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
POE	Extended Depth Of Focus Intraocular Lens

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P210005	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0ec3b18a-557a-49cb-8b9d-97269922b516
Public Version Date: June 21, 2024
Public Version Number: 2
DI Record Publish Date: January 04, 2023

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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