DEVICE: NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE (00383790000130)

Device Identifier (DI) Information

NIPRO SAFETOUCH™ II SAFETY FISTULA NEEDLE
16GX1" HTC-30W
In Commercial Distribution
FS+162530BCR
NIPRO MEDICAL CORPORATION
00383790000130
GS1

1
797372554 *Terms of Use
16Gx1" Rotating Hub 12" Tubing
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
FOZ Catheter,intravascular,therapeutic,short-term less than 30 days
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

c4542094-4697-4420-a1b9-52922cb598d3
March 29, 2018
2
April 20, 2016
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
10383790000137 50 00383790000130 In Commercial Distribution Carton
40383790000138 10 10383790000137 In Commercial Distribution Case
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE