DEVICE: NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER (00383790001274)

Device Identifier (DI) Information

NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER
15GX1-1/4" HC-30W-D-CAP
In Commercial Distribution
FD+153230BC-CAP
NIPRO MEDICAL CORPORATION
00383790001274
GS1

1
797372554 *Terms of Use
DULL FISTULA NEEDLE for Established Access Sites Only 15Gx1-1/4" Fixed Hub 12" Tubing
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Device Characteristics

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

GMDN

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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.
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FDA Product Code

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Product Code Product Code Name
FIE Needle, fistula
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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
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

1fec5be9-13c7-4034-9b66-e8bfcc614046
March 29, 2018
2
April 01, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
40383790001272 10 10383790001271 In Commercial Distribution Case
10383790001271 50 00383790001274 In Commercial Distribution Carton
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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