AccessGUDID - DEVICE: Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit (00850001913102)

GUDID

Device Identifier (DI) Information

Brand Name: Fascile Continuous Peripheral Nerve Block Catheter and Needle Kit
Version or Model: 500020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Solo-Dex, Inc

Primary DI Number: 00850001913102
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 118663297 *Terms of Use

Device Description: Mini-Kit, 100mm w/ filter

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
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: Yes

Sterilization Method [?]
Ethylene Oxide

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: e7a16b86-dd6b-44e4-901e-65ba6d02d7c5
Public Version Date: May 17, 2023
Public Version Number: 1
DI Record Publish Date: May 09, 2023