| Primary Device ID | 50051131000204 |
| NIH Device Record Key | dd6e03f7-cc47-4280-a112-184b83df00b9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 3M™ Nexcare™ Durapore™ |
| Version Model Number | 538-P1 |
| Catalog Number | 538-P1 |
| Company DUNS | 830016148 |
| Company Name | 3M COMPANY |
| Device Count | 12 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | +1(800)537-2191 |
| 3Mhealthcarecompliance@mmm.com | |
| Phone | +1(800)537-2191 |
| 3Mhealthcarecompliance@mmm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00051131000209 [Unit of Use] |
| GS1 | 30051131000200 [Primary] |
| GS1 | 50051131000204 [Package] Contains: 30051131000200 Package: BOX [3 Units] In Commercial Distribution |
| KGX | Tape and bandage, adhesive |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2018-09-25 |
| 50051131000211 | Nexcare™ Durapore™ Cloth Tape, 538-P1, 2 in x 10 yds, Rolled |
| 50051131000204 | Nexcare™ Durapore™ Cloth Tape, 538-P1, 1 in x 10 yds, Rolled |