| Primary Device ID | 45060259070400 |
| NIH Device Record Key | 7dbf95ea-51a0-4644-8e06-b252b7e9b4c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sigma Swab |
| Version Model Number | N/a |
| Catalog Number | MW941 |
| Company DUNS | 216096750 |
| Company Name | MEDICAL WIRE & EQUIPMENT CO.(BATH)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 | false |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060259070402 [Primary] |
| GS1 | 35060259070403 [Unit of Use] |
| GS1 | 45060259070400 [Package] Contains: 05060259070402 Package: Box [2000 Units] In Commercial Distribution |
| KXG | Applicator, Absorbent Tipped, Sterile |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-13 |
| Device Publish Date | 2023-10-05 |
| 45060259070486 | Sigma swab ENT |
| 25060259070444 | Sigma swab 2x Sigma swab individual |
| 25060259070420 | Sigma swab Ent with breakpoint |
| 45060259070400 | Sigma swab - polyurethane |
| 25060259070383 | Sigma swab individually wrapped |