| Primary Device ID | 00850004725115 |
| NIH Device Record Key | 6f02f7dc-f420-4443-8df9-1553e919f883 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Barrigel Applicator Needle |
| Version Model Number | 3009-2 |
| 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 | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Needle Gauge | 18 Gauge |
| Length | 20 Centimeter |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Storage Environment Temperature | Between 0 Degrees Fahrenheit and 25 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004725115 [Primary] |
| OVB | Hydrogel Spacer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-08 |
| Device Publish Date | 2022-11-30 |
| 00850004725139 - Barrigel | 2023-03-09 Barrigel convenience kit |
| 00850004725108 - Barrigel | 2022-12-08 Hydrogel (HA) Injectable Rectal Spacer |
| 00850004725115 - Barrigel Applicator Needle | 2022-12-08Hypodermic needles for the injection of Barrigel |
| 00850004725115 - Barrigel Applicator Needle | 2022-12-08 Hypodermic needles for the injection of Barrigel |
| 00850004725023 - Deflux Metal Needle | 2019-03-11 Deflux Metal Needle |
| 00850004725009 - Deflux | 2019-03-04 Deflux |
| 00850004725016 - Solesta | 2019-03-04 Solesta |