| Primary Device ID | 00816953027014 |
| NIH Device Record Key | 317d56ac-ec5f-40e8-8e49-9fb056fac5c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E5460/N Band Bag with tape 91x76cm- 36"x30" |
| Version Model Number | E5460/N |
| Company DUNS | 014464314 |
| Company Name | EXACT MEDICAL MANUFACTURING, 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 | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com | |
| Phone | 716-681-0866 |
| rdean@exactmm.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00816953027007 [Primary] |
| GS1 | 00816953027014 [Package] Contains: 00816953027007 Package: Inner Case [43 Units] In Commercial Distribution |
| GS1 | 00816953027021 [Package] Contains: 00816953027007 Package: Case [86 Units] In Commercial Distribution |
| KKX | Drape, Surgical |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-11 |
| 00816953027045 | E5460/N |
| 00816953027014 | E5460/N |