AccessGUDID - DEVICE: NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE (00383790007511)

GUDID

Device Identifier (DI) Information

Brand Name: NIPRO SAFETOUCH™ II GAMMA SAFETY FISTULA NEEDLE
Version or Model: 18G X 1-1/4"
Commercial Distribution Status: In Commercial Distribution
Catalog Number: FS+183230BC-G
Company Name: NIPRO MEDICAL CORPORATION

Primary DI Number: 00383790007511
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 797372554 *Terms of Use

Device Description: 18Gx1-1/4" Fixed Hub 11" Tubing

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?
12741	Haemodialysis needle	A sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FIE	Needle, fistula

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
Length: 1.25 Inch
Needle Gauge: 18 Gauge

Device Record Status

Public Device Record Key: 5cf503f6-f498-40af-bb63-22572a7d3291
Public Version Date: September 26, 2019
Public Version Number: 1
DI Record Publish Date: September 18, 2019