AccessGUDID - DEVICE: Aligned Medical Solutions (B098AMS14760A0)

GUDID

Device Identifier (DI) Information

Brand Name: Aligned Medical Solutions
Version or Model: AMS14760A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMS14760A
Company Name: Aligned Medical Solutions

Primary DI Number: B098AMS14760A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106580145 *Terms of Use

Device Description: LASIK KIT - LATEX SAFE

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:	Yes
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?
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OJK	Eye Tray

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 64aa2ee4-dc92-41b0-850c-7729371bac21
Public Version Date: July 03, 2024
Public Version Number: 1
DI Record Publish Date: June 25, 2024