AccessGUDID - DEVICE: Adato SIL-OL-5000 (00757770516315)

GUDID

Device Identifier (DI) Information

Brand Name: Adato SIL-OL-5000
Version or Model: ES 5000 S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ES 5000 S
Company Name: Bausch & Lomb Incorporated

Primary DI Number: 00757770516315
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196603781 *Terms of Use

Device Description: ADATO SIL-OL 5000 SYRINGE

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?
45125	Vitreous humour replacement medium, postoperative	A fluid or semifluid substance (e.g., silicone oil with or without a perfluorocarbon, or a semifluorinated alkane) intended to be used to compress/unfold the retina (up to weeks/months) to support its reattachment following the operative treatment of severe retinal detachment; it might in addition be intended for transient intraoperative use (e.g., to remove silicone oil residues). Often referred to as a retinal tamponade, it is intended to realign the retina by exerting a force against it without flowing behind it. It is typically removed after a period depending upon clinical findings. It may be supplied in a prefilled syringe or other container. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWL	Fluid, Intraocular

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: 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: f68b26c3-aeaa-45f9-aa04-bc07323ce95e
Public Version Date: May 15, 2024
Public Version Number: 5
DI Record Publish Date: September 25, 2014