| Primary Device ID | 00816953026673 |
| NIH Device Record Key | bf7e1980-5d31-42eb-9e2c-ef33146db554 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E5322N Probe Cover Elastic Poly 6" x 48" |
| Version Model Number | E5322N |
| Catalog Number | E5322N |
| 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 | 00816953026666 [Primary] |
| GS1 | 00816953026673 [Package] Contains: 00816953026666 Package: Case [800 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 | 2016-10-17 |
| 16975424198729 - Proficient Surgical | 2026-03-19 INTRAOPERATIVE PROBE DRAPE, 5” X 96" |
| 16975424198736 - Proficient Surgical | 2026-03-19 DELUXE VIDEO CAMERA DRAPE, 7” X 96" |
| 26975424198832 - Exact Medical Manufacturing, Inc. | 2026-03-17 Sterile Covers for VPS G4 Console |
| 16975424199276 - Exact Medical Manufacturing, Inc. | 2026-03-17 Cover for Xray Screen 160x160cm |
| 26975424198443 - Exact Medical Manufacturing, Inc. | 2026-03-13 UNIVERSAL GAMMA PROBE CVR 1.25in. x 12in. (3cm x30.5cm) |
| 26975424198450 - Exact Medical Manufacturing, Inc. | 2026-03-13 ANGLED WIRELESS GAMMA PROBE CVR 1.25in.x10.25in.(3cm x 26cm) |
| 26975424198467 - Exact Medical Manufacturing, Inc. | 2026-03-13 UNIVERSAL GAMMA PROBE COVER 5in. x 96in. (13cm x 244cm) |
| 16975424196206 - Exact Medical Manufacturing, Inc. | 2026-01-13 Robot Arm Sterile Drape |