MICROTEK
GUDID 50748426095501
ACS HEADGEAR - FRAME XL, 1-CASE
Microtek Medical Inc.
Surgical helmet| Primary Device ID | 50748426095501 |
| NIH Device Record Key | 6809171b-8371-482d-b197-e486fc987749 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MICROTEK |
| Version Model Number | 1 |
| Company DUNS | 106908437 |
| Company Name | Microtek Medical 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
| Special Storage Condition, Specify | Between 0 and 0 *Store under normal warehouse conditions. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 50748426095501 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K910515
FDA Product Code
| FYA | GOWN, SURGICAL |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-03-17 |
On-Brand Devices [MICROTEK]
| 50748426075411 | REPLACEMENT VALVE FOR MICROMASK, 1-EACH |
| 50748426046961 | 5'' AIR TUBING ASSY (MODEL 610), 1-EACH |
| 50748426121446 | DISPOSABLE DRAPE FOR STANDARD CRANIAL REFERENCE ARRAY, 1-EACH |
| 50748426121262 | INTRAOPERATIVE PROBE COVER W/O GEL, 5" X 96", 1-EACH |
| 50748426121248 | ZEE MICROSHIELD TAMPER EVIDENT, 1-EACH |
| 50748426121231 | ZEE TAMPER EVIDENT MICROSHIELD, 1-EACH |
| 50748426121224 | CPR MICROSHIELD, 1-EACH |
| 30748426121213 | GALLS CPR MICROKEY PRO ROYAL, 1-EACH |
| 30748426121206 | GALLS CPR MICROKEY PRO BLACK, 1-EACH |
| 30748426121190 | GALLS CPR MICROKEY ROYAL, 1-EACH |
| 30748426121183 | GALLS CPR MICROKEY ORANGE, 1-EACH |
| 50748426121170 | GALLS CPR MICROKEY BLACK, 1-EACH |
| 30748426121169 | GALLS CPR MICROSHIELD, 1-EACH |
| 50748426121149 | CPR MICROKEY RED, 1-EACH |
| 50748426121132 | ARMSTRONG CPR MICROMASK, 1-EACH |
| 50748426121125 | ARMSTRONG MICROMASK, 1-EACH |
| 50748426121118 | ARMSTRONG MICROMASK, 1-EACH |
| 50748426121101 | ARMSTRONG MICROKEY, 1-EACH |
| 50748426121095 | ARMSTRONG MICROSHIELD, 1-EACH |
| 50748426121088 | AED FIRST RESPONDER KIT, 1-EACH |
| 50748426121071 | CPR MICROMASK BLUE HARD CASE, 1-EACH |
| 50748426121057 | NORTH MICROKEY BLACK W/O LABEL |
| 50748426120968 | PROTECTIVE BAG FOR TWIN PEDAL FOOT, 1-EACH |
| 50748426120951 | ROLLED PROBE COVER |
| 50748426008976 | BANDED BAG W/RUBBERBAND W/TAPE,36""X, 1-EACH |
| 50748426120814 | EMBOSSED PLASTIC DRP, 1-EACH |
| 50748426120647 | ENDOCAVITY TAPER 10CM X 4.4CM X 25CM |
| 30748426120629 | GENERAL PURPOSE PC, 1-EACH |
| 50748426120609 | CAMERA DRAPE, 7'' X 96'', 1-EACH |
| 50748426120395 | MICROSCOPE DRAPE, 1-EACH |
| 50748426074407 | AUTO EXTERNAL DEFIBRILLATION, 1-EACH |
| 50748426120364 | MICROSCOPE DRAPE, 1-EACH |
| 50748426120357 | MICROSCOPE DRAPE, 1-EACH |
| 50748426120340 | MICROSCOPE DRAPE ZEISS MD 54 X 32 X 64, 1-EACH |
| 50748426120333 | MICROSCOPE DRAPE, 1-EACH |
| 50748426120258 | DRAPE ANGIO W/ CUSTOM TROUGH |
| 50748426120173 | MED LINK MICROSCOPE DRAPE, 1-EACH |
| 30748426119999 | CAMERA DRAPE, 1-EACH |
| 50748426119986 | MITAKA POINT SETTER & CHAIR ARM DRAPE, 1-EACH |
| 50748426119948 | V DRIVE DRAPE |
| 30748426119937 | STEREOTAXIS NIOBE COVER DRAPE |
| 50748426119924 | UTERINE POSITIONING SYSTEM STERILE DRAPE, 1-EACH |
| 50748426119917 | REMOTE CONTROL DRAPE, 1-EACH |
| 50748426119887 | REMOTE CONTROL COVER PACK, 1-EACH |
| 50748426119870 | PATIENT ISOLATION DRAPE, 1-EACH |
| 50748426119863 | PATIENT ISOLATION DRAPE, 1-EACH |
| 50748426119832 | TELELAP ALF-X MANIPULATOR COVER, 1-EACH |
| 50748426119825 | TELELAP ALF-X RADIA DRAPE, 1-EACH |
| 50748426119818 | TELELAP ALF-X MANIPULATOR COVER, 1-EACH |
| 30748426119791 | INTRAOPERATIVE PROBE COVER |
Trademark Results [MICROTEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MICROTEK 88301892 not registered Live/Pending |
Fusion Optix, Inc. 2019-02-14 |
 MICROTEK 87633574 5496159 Live/Registered |
SYNATEK LP 2017-10-04 |
 MICROTEK 86919715 5216223 Live/Registered |
Fleurco Products Inc. 2016-02-25 |
 MICROTEK 77263723 not registered Dead/Abandoned |
United States Liability Insurance Company and its affiliates 2007-08-24 |
 MICROTEK 76572201 2924836 Live/Registered |
MICROTEK MEDICAL, INC. 2004-01-23 |
 MICROTEK 76512696 2852990 Dead/Cancelled |
Kaydon Acquisition XI, Inc. 2003-05-08 |
 MICROTEK 75606937 not registered Dead/Abandoned |
Marburger Packing 1998-12-17 |
 MICROTEK 75555278 2494685 Dead/Cancelled |
SEALY TECHNOLOGY, LLC 1998-09-18 |
 MICROTEK 75387572 2277271 Live/Registered |
Microtek International Inc. 1997-11-10 |
 MICROTEK 73754327 not registered Dead/Abandoned |
MESSAGETECH PTY LIMITED 1988-09-22 |
 MICROTEK 73500210 1339096 Live/Registered |
Broan Mfg. Co., Inc. 1984-09-20 |
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