AccessGUDID - DEVICE: AVANOS* (00193493000494)

GUDID

Device Identifier (DI) Information

Brand Name: AVANOS*
Version or Model: 181A482
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 181A482
Company Name: Avanos Medical, Inc.

Primary DI Number: 00193493000494
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 079375431 *Terms of Use

Device Description: Nerve Block Trays, Qty 20 - 181A482

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":	Yes
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?
46382	Peripheral anaesthesia single-administration set, non-medicated	A collection of devices intended for the single-administration of an anaesthetic agent (not included) to function as a peripheral nerve-block; it is not dedicated to dental use. It includes an anaesthesia needle and a syringe often with additional devices utilized for the procedure (e.g., dressings); as a single-administration set it does not include a catheter. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BSP	NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

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: 31301b4f-ac16-4a14-a38d-e02b89b5483d
Public Version Date: February 28, 2024
Public Version Number: 3
DI Record Publish Date: May 19, 2021