FDA.reportPublic FDA data

NA

Primary DI
10810030860249
Brand
NA
Company
MID CENTRAL MEDICAL CORP.
Model
OTA107
Catalog number
OTA107
Device description
Anesthesia Protection Shield. This stainless steel anesthesia shield is designed to protect the patient’s face during surgery and also provides a frame for the anesthesia drape. Constructed of durable stainless steel, it attaches to the OR table rail with two stainless steel side rail sockets (MCM-162 sold separately). Top surface measures 18 1/4" by 22 1/4" and the side supports are 24"L to adjust to the desired height. Side supports measure 1/8" x 1". The flat tray portion can be used to support instruments during surgery. Allows full patient access for anesthesia monitoring. Fully welded stainless steel construction makes it easy to clean and durable.
Published
2020-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FWZOperating Room Accessories Table Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FWZOperating Room Accessories Table TrayGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810030860249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081003086024910810030860249

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia screenA frame-like device designed to provide a barrier between the sterile surgical site (i.e., where the surgeon operates) and the non-sterile area where the anaesthesiologists and other staff work during a procedure. It is typically fixed to the side rail of the operating table, and surgical drapes are hung over it or from it to create the hygienic partition. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Width0

Contacts#

Phone, Email table
PhoneEmail
701-825-6100office@midcentralmedical.com

Regulatory Flags#

DUNS number
076907973
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810030861772NATBL5106TBL51062020-11-16
10810030861789NATBL5107TBL51072020-11-16
10810030861796NATBL5108TBL51082020-11-16
10810030861802NATBL5109TBL51092020-11-16
10810030861819NATBL5060TBL50602020-11-16
10810030861826NATBL5061TBL50612020-11-16
10810030861833NATBL5062TBL50622020-11-16
10810030861840NATBL5063TBL50632020-11-16
10810030861857NATBL5064TBL50642020-11-16
10810030861864NATBL5065TBL50652020-11-16
10810030861871NATBL5066TBL50662020-11-16
10810030861680NATBL5006TBL50062020-10-31
10810030861697NATBL5007TBL50072020-10-31
10810030861703NATBL5008TBL50082020-10-31
10810030861710NATBL5009TBL50092020-10-31
10810030861727NATBL5101TBL51012020-10-31
10810030861734NATBL5102TBL51022020-10-31
10810030861741NATBL5103TBL51032020-10-31
10810030861758NATBL5104TBL51042020-10-31
10810030861765NATBL5105TBL51052020-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843059127331LattusTEDAN SURGICAL INNOVATIONS, L.L.C.FWZ2026-07-20
00696588008394De Mayo D2® Knee Positioner®Innovative Medical Products, IncFWZ2026-06-23
07640152574245FISSOBaitella AGFWZ2026-04-01
07640152574252FISSOBaitella AGFWZ2026-04-01
07640152574269FISSOBaitella AGFWZ2026-04-01
07640152574276FISSOBaitella AGFWZ2026-04-01
07640152574283FISSOBaitella AGFWZ2026-04-01
07640152573989FISSOBaitella AGFWZ2025-10-13
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-22
10197344149803MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149810MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
10197344149827MEDLINEMEDLINE INDUSTRIES, INC.FWZ2025-09-12
B382SD40090530Surgical DirectSurgical Direct, Inc.FWZ2025-08-05
10192253053777DevonCardinal Health 200, LLCFWZ2025-03-21
04250407786663FENTEXFENTEX medical GmbHFWZ2024-12-28
04250407786670FENTEXFENTEX medical GmbHFWZ2024-12-28
10197344072033MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
10197344120802MEDLINEMEDLINE INDUSTRIES, INC.FWZ2024-12-26
08056646508570Transparent drape 40x50 cm with adhesive tape for physiodispensers or for controOMNIA SRLFWZ2023-06-28
08056646508594Sheaths 120x7 cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508617Sheaths 240x7 cm cm with fixing elasticsOMNIA SRLFWZ2023-06-28
08056646508631Sheaths 120x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508655Sheaths 240x7 cm with adhesive fixing tapesOMNIA SRLFWZ2023-06-28
08056646508778OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508792OmnisleeveOMNIA SRLFWZ2023-06-28
08056646508815Barrier sleeves for Osstell Beacon ISQ device - sterileOMNIA SRLFWZ2023-06-28
00615521015299ALLENHILL-ROM, INC.FWZ2023-05-31
00615521014476ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014599ALLENHILL-ROM, INC.FWZ2023-05-30
00615521014650ALLENHILL-ROM, INC.FWZ2023-05-30