DEVICE: Atlanta Healthcare Services OcuDrape® (10852171007183)
Device Identifier (DI) Information
Atlanta Healthcare Services OcuDrape®
10852171007183
In Commercial Distribution
DRA7352
ATLANTA HEALTHCARE SERVICES, INC.
10852171007183
In Commercial Distribution
DRA7352
ATLANTA HEALTHCARE SERVICES, INC.
Cover, Mayo Cover Clear Plastic, Phaco Tray Cover with Cuff 24" Wide
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
12535 | Medical equipment/instrument drape, single-use |
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KKX | Drape, surgical |
PUI | Drape, Surgical, Exempt |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 42 Inch |
Width: 24 Inch |
Device Record Status
609cfe54-906e-45a0-b6b3-7bf89bb09544
September 11, 2024
5
November 14, 2016
September 11, 2024
5
November 14, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00852171007186
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(404)812-9886
service@ocudrape.com
service@ocudrape.com