Primary Device ID | 26975085709880 |
NIH Device Record Key | 0226f4cb-28c2-41d0-a625-a54383a2e1ca |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Tecfen Medical |
Version Model Number | QDR1061 |
Catalog Number | QDR1061 |
Company DUNS | 014464314 |
Company Name | EXACT MEDICAL MANUFACTURING, INC. |
Device Count | 1 |
DM Exempt | true |
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 | false |
Labeled No Natural Rubber Latex | true |
RX Perscription | false |
OTC Over-The-Counter | true |
Device Issuing Agency | Device ID |
---|---|
GS1 | 06975085709886 [Primary] |
GS1 | 26975085709880 [Package] Contains: 06975085709886 Package: Case [80 Units] In Commercial Distribution |
KKX | Drape, Surgical |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-04-12 |
Device Publish Date | 2023-04-04 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TECFEN MEDICAL 85846328 4410512 Live/Registered |
Soft Logic, Inc. 2013-02-11 |
TECFEN MEDICAL 85845095 4497045 Live/Registered |
Soft Logic, Inc 2013-02-08 |