| Primary Device ID | 00384705405033 |
| NIH Device Record Key | 597e5e88-68e7-4fb7-8426-8b3979fba0b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neurotips |
| Version Model Number | NT 0100 |
| Company DUNS | 217266915 |
| Company Name | OWEN MUMFORD LIMITED |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | 770-977-2226 |
| info.us@owenmumford.com | |
| Phone | 770-977-2226 |
| info.us@owenmumford.com |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384705405002 [Unit of Use] |
| GS1 | 00384705405019 [Primary] |
| GS1 | 00384705405026 [Package] Contains: 00384705405019 Package: Sleeve [5 Units] In Commercial Distribution |
| GS1 | 00384705405033 [Package] Contains: 00384705405026 Package: Case [20 Units] In Commercial Distribution |
| GXB | Esthesiometer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-10-11 |
| Device Publish Date | 2019-10-03 |
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| 00384701614033 - Unistik Pro | 2023-02-15 Unistik Pro Safety Lancet - 21G x 2.0mm |
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| 00384701404030 - Unistik Touch - Contact Activated Safety Lancet - 23G x 2.0mm | 2021-04-12 Sterile, single use safety lancet |
| 00384701412035 - Unistik Touch - Contact Activated Safety Lancet - 21G x 2.0mm | 2021-04-12 Sterile, single use safety lancet |