Model: SD-A16G
DI: 04711552764857
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-24
Current Version: 2026-05-04
Description
S-04-C15-B-03
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
447143f5-1a72-4009-a2dc-780326ed4487
Distribution Status:
In Commercial Distribution
DUNS Number:
657715348
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04711552764857
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 12741
Name: Haemodialysis needle
Definition:
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.
FDA Product Codes
FIE
Needle, Fistula
Premarket Submissions
Submission Number:
K003123
Supplement Number:
000