Primary Device ID | 00816953021012 |
NIH Device Record Key | ffd9dcf7-9570-47bc-9e30-a157c9d1a8ea |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | E5107N Cover, Back Table, 150x240cm PSB (Absorbent Reinforcement) -60x240cm |
Version Model Number | E5107N |
Catalog Number | E5107N |
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 | true |
OTC Over-The-Counter | false |
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 | 00816953021005 [Primary] |
GS1 | 00816953021012 [Package] Contains: 00816953021005 Package: Case [360 Units] In Commercial Distribution |
FYA | Gown, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2019-10-23 |
Device Publish Date | 2016-10-07 |
26975424195237 - Exact Medical Manufacturing | 2024-04-04 Hemorrhage View C-Section Drape, Sterile, Pear Shaped fenestration within incision panel |
26975424195251 - Exact Medical Manufacturing | 2024-04-04 Hemorrhage View C-Section Drape,Sterile, full incision panel |
16975424195285 - Exact Medical Manufacturing | 2024-04-04 Foot Switch Cover with drawstring 36x76cm - 14"x30" |
16975085705526 - Exact Medical | 2024-03-27 Foot Switch Cover, Drawstring and adjuster 56x51cm - 22"x20" |
16975424194653 - 3M | 2023-12-26 Instrument Table Cover 100cmx150cm (76cmx150cm reinf) UDI-DI - 159309803EQCJL |
16975424194660 - 3M | 2023-12-26 Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI-159309803EQCJL |
16975424194677 - 3M | 2023-12-26 Instrument Table Cover 200cmx228cm (90cmx228cm reinf) UDI-DI - 159309803EQCJL |
16975424194684 - 3M | 2023-12-26 Instrument Table Cover 152cmx200cm (76cmx200cm reinf) UDI-DI - 159309803EQCJL |