AccessGUDID - DEVICE: NIPRO SafeTouch™ Safety Scalp Vein Set (00383790002608)

GUDID

Device Identifier (DI) Information

Brand Name: NIPRO SafeTouch™ Safety Scalp Vein Set
Version or Model: SPR+23G19
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NIPRO MEDICAL CORPORATION

Primary DI Number: 00383790002608
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 797372554 *Terms of Use

Device Description: No description.

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:	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?
35211	Scalp vein needle	A very slender, sterile, sharp bevel-edged, hollow tubular metal instrument designed for use on the veins of the scalp or other small veins, especially in paediatric patients. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FOZ	Catheter,intravascular,therapeutic,short-term less than 30 days
FMI	Needle, hypodermic, single lumen

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
Device Size Text, specify: NeedleLength : 3/4 Inch
Device Size Text, specify: Tubing Length : 12 Inch
Device Size Text, specify: Needle Gauge : 23 Gauge

Device Record Status

Public Device Record Key: 5faf250f-28ae-408b-ab67-8e7d0a90a7bb
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 16, 2016