AccessGUDID - DEVICE: N/A (00858965006175)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: TDL108
Commercial Distribution Status: In Commercial Distribution
Catalog Number: N/A
Company Name: PAJUNK MEDICAL SYSTEMS, LP

Primary DI Number: 00858965006175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 136718553 *Terms of Use

Device Description: SonoLong Sono Tray 18G x 2'' (50mm) echogenic needle with Tuohy tip, 60cm injection tubing, 60cm stimulation cable, SonoLong Sono 20G x 20'' (50cm) echogenic catheter with closed tip and 3 lateral openings, catheter container with introducer aid, 30cm graduation, helical coil, steel stylet, clamping adapter

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:	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?
64347	Peripheral anaesthesia catheter set, medicated	A collection of devices intended for the continuous-administration of an anaesthetic agent to function as a peripheral nerve-block. It includes a pharmaceutical anaesthetic agent, an anaesthesia catheter, and an anaesthesia needle usually with additional devices utilized for the procedure (e.g., connectors, catheter holder). This is a single-use device.	Active	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: 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: f400a50c-3692-4407-86d2-e9682d2b453d
Public Version Date: January 24, 2024
Public Version Number: 1
DI Record Publish Date: January 16, 2024