Primary Device ID | 10850002860716 |
NIH Device Record Key | 27e7f8b8-8be8-438e-a713-187321eafb57 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Comfort EZ Pro |
Version Model Number | SPN-31G5 |
Catalog Number | 50002-0860-71 |
Company DUNS | 116722847 |
Company Name | S.D.I. USA, INC. |
Device Count | 100 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Needle Gauge | 31 Gauge |
Length | 5 Millimeter |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850002860719 [Primary] |
GS1 | 10850002860716 [Package] Contains: 00850002860719 Package: Case [12 Units] In Commercial Distribution |
GS1 | 20850002860713 [Unit of Use] |
FMI | Needle, Hypodermic, Single Lumen |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-08-09 |
Device Publish Date | 2023-08-01 |
10850002860723 | Safety Insulin Pen Needles - 31G 4mm 100 count |
10850002860716 | Safety Insulin Pen Needles - 31G 5mm 100 count |
10850002860709 | Safety Insulin Pen Needles - 30G 8mm 100 count |