| 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 |