AccessGUDID - DEVICE: Aligned Medical Solutions (B098AMS11225A0)

GUDID

Device Identifier (DI) Information

Brand Name: Aligned Medical Solutions
Version or Model: AMS11225A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AMS1125A
Company Name: Aligned Medical Solutions

Primary DI Number: B098AMS11225A0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106580145 *Terms of Use

Device Description: UNIVERSAL BLOCK TRAY - RX

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:	Yes
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?
61911	Epidural anaesthesia set, medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent to the epidural space for the management of pain. It includes the pharmaceutical anaesthetic agent and a needle, with additional devices utilized for the procedure (e.g., syringe, dressings), and may include a catheter (i.e., may be intended for single- or continuous-administration). It is not intended for intrathetcal anaesthesia. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OGE	Epidural Anesthesia Kit

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 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4477f325-d349-4fd4-881e-b443cd258424
Public Version Date: June 22, 2023
Public Version Number: 1
DI Record Publish Date: June 14, 2023