Primary Device ID | 00850004725023 |
NIH Device Record Key | 8c024a4e-a6eb-49b0-8d57-1ea470be0b8f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Deflux Metal Needle |
Version Model Number | 3.7 FR x 23 G (tip) x 350 mm |
Company DUNS | 116951700 |
Company Name | PALETTE LIFE SCIENCES, INC. |
Device Count | 1 |
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 | true |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Length | 350 Millimeter |
Needle Gauge | 23 Gauge |
Handling Environment Temperature | Between 0 Degrees Fahrenheit and 77 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850004725023 [Primary] |
LMN | Ceramics, Calcium Triphosphate/Hydroxypatite, Non-Load Bearing Uses |
LNM | Agent, Bulking, Injectable For Gastro-Urology Use |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-03-11 |
Device Publish Date | 2019-02-11 |
00850004725139 - Barrigel | 2023-03-09 Barrigel convenience kit |
00850004725108 - Barrigel | 2022-12-08 Hydrogel (HA) Injectable Rectal Spacer |
00850004725115 - Barrigel Applicator Needle | 2022-12-08 Hypodermic needles for the injection of Barrigel |
00850004725023 - Deflux Metal Needle | 2019-03-11Deflux Metal Needle |
00850004725023 - Deflux Metal Needle | 2019-03-11 Deflux Metal Needle |
00850004725009 - Deflux | 2019-03-04 Deflux |
00850004725016 - Solesta | 2019-03-04 Solesta |