AccessGUDID - DEVICE: Fascile Continuous Peripheral Nerve Block Set (B372500001021)

GUDID

Device Identifier (DI) Information

Brand Name: Fascile Continuous Peripheral Nerve Block Set
Version or Model: 70mm, Kit without filter
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 500001-02
Company Name: Solo-Dex, Inc

Primary DI Number: B372500001021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118663297 *Terms of Use

Device Description: Solo-Dex Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit is a needle comprised of an open tip catheter over a needle. Fascile kit is comprised of different key components required to complete the Peripheral Nerve Block procedure.

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?
61547	Peripheral nerve-block sharp needle	A sterile, sharp bevel-edged, hollow tubular metal instrument intended to invasively access a peripheral nerve to inject 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 may be used to deliver anaesthetic or analgesic agents directly and/or to allow introduction of a dedicated catheter for administration. 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 [?]
K151072	000

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
Length: 70 Millimeter

Device Record Status

Public Device Record Key: 6f1de0a4-0398-41ba-8b0b-f281a1f01082
Public Version Date: June 15, 2022
Public Version Number: 4
DI Record Publish Date: September 26, 2016