AccessGUDID - DEVICE: Biolon (00369918000008)

GUDID

Device Identifier (DI) Information

Brand Name: Biolon
Version or Model: version 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 62501
Company Name: AMRING PHARMACEUTICALS INC.

Primary DI Number: 00369918000008
Issuing Agency: GS1
Commercial Distribution End Date: September 15, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 079843051 *Terms of Use

Device Description: Viscoelastic surgical aid

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):	Yes
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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35907	Vitreous/aqueous humour replacement medium, intraoperative	A nonimplantable artificial fluid, semifluid, or viscoelastic substance intended to be used to replace the vitreous or aqueous humour within the eye to help facilitate the performance of ophthalmic surgery (e.g., to maintain the shape of the eyeball during the intervention, preserve tissue integrity, protect from surgical trauma, and/or to function as a tamponade during retinal reattachment). It may be supplied in a prefilled sterile syringe or other container. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LZP	AID, SURGICAL, VISCOELASTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Do not Freeze
Special Storage Condition, Specify: Protect from light
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 ml of Biolon solution in prefilled syringe
Total Volume: 1 Milliliter

Device Record Status

Public Device Record Key: 2749f09b-5e7c-439c-986a-e3a4ed6a8fed
Public Version Date: November 27, 2023
Public Version Number: 5
DI Record Publish Date: May 17, 2018