AccessGUDID - DEVICE: Discseel (B875DSCLID0)

GUDID

Device Identifier (DI) Information

Brand Name: Discseel
Version or Model: DSCLID
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DSCLID
Company Name: Custom Interventional Pain Management, LLC

Primary DI Number: B875DSCLID0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030406006 *Terms of Use

Device Description: Convenience kit with Lidocaine

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?
64349	Intrathecal anaesthesia set, medicated	A collection of devices intended for the single-administration of an analgesic or anaesthetic agent to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes the pharmaceutical anaesthetic agent, spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFU	Spinal 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: 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: dce6d1f2-4a01-483d-bae9-43043b914424
Public Version Date: August 23, 2023
Public Version Number: 1
DI Record Publish Date: August 15, 2023