AccessGUDID - DEVICE: EpiSpin II SAFETY (04048223072639)

GUDID

Device Identifier (DI) Information

Brand Name: EpiSpin II SAFETY
Version or Model: 0021451-30
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0021451-30
Company Name: Pajunk GmbH Medizintechnologie

Primary DI Number: 04048223072639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 317654283 *Terms of Use

Device Description: EpiSpin II SAFETY Tuohy with backeye and wings 18G x 90cm, Sprotte Standard with

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):	No
Over the Counter (OTC):	No
Kit:	No
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
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Storage Environment Humidity: between 20 and 65 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 90.0 Millimeter
Needle Gauge: 18.0 Gauge

Device Record Status

Public Device Record Key: 6a5a1a87-a245-4197-9b8b-1420d5e6c956
Public Version Date: February 07, 2025
Public Version Number: 1
DI Record Publish Date: January 30, 2025