AccessGUDID - DEVICE: Aligned Medical Solutions (B098AM6040B0)

GUDID

Device Identifier (DI) Information

Brand Name: Aligned Medical Solutions
Version or Model: AM6040B
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM6040B
Company Name: Aligned Medical Solutions

Primary DI Number: B098AM6040B0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106580145 *Terms of Use

Device Description: Universal Block Kit

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?
59013	Peripheral nerve-block blunt needle/cannula kit	A collection of sterile devices intended to provide percutaneous access to a peripheral nerve group for injection of an anaesthetic/analgesic agent for nerve-block/pain control (e.g., sleeve blocks, deep muscle blocks, hypogastric blocks, paravertebral blocks, joint blocks, selective nerve root, lumbar sympathetic, Coeliac plexus). It typically consists of a plastic nerve-block blunt needle access cannula and a metal nerve-block blunt needle. The cannula is intended to gain percutaneous access, which may be guided by fluoroscopy, to provide a conduit for insertion of the needle for administration of the pharmaceutical. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
OGJ	Nerve block 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: b4a1d48a-7ba5-47f6-acf4-53b9359db7b9
Public Version Date: December 03, 2018
Public Version Number: 1
DI Record Publish Date: November 01, 2018