AccessGUDID - DEVICE: EpiSpin Soft NRFit (04048223029220)

GUDID

Device Identifier (DI) Information

Brand Name: EpiSpin Soft NRFit
Version or Model: 131166-608
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 131166-608
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223029220
Issuing Agency: GS1
Commercial Distribution End Date: March 15, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: EpiSpin Soft NRFit Tuohy NRFit 17G x 90mm with back eye and wings

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?
46308	Epidural/intrathecal anaesthesia set, non-medicated	A dual-purpose collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space and to the epidural space for the management of pain. It includes both a spinal needle and an epidural needle with additional devices utilized for the procedure (e.g., dressings, syringe) and may include an epidural catheter for continuous-administration. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CAZ	Anesthesia conduction kit

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: daa50a7b-cad2-49a9-8923-5355381b6cc3
Public Version Date: March 17, 2025
Public Version Number: 4
DI Record Publish Date: April 16, 2019