DEVICE: Atlanta Healthcare Services OcuDrape® (10852171007183)

Device Identifier (DI) Information

Atlanta Healthcare Services OcuDrape®
10852171007183
In Commercial Distribution
DRA7352
ATLANTA HEALTHCARE SERVICES, INC.
10852171007183
GS1

50
130599421 *Terms of Use
Cover, Mayo Cover Clear Plastic, Phaco Tray Cover with Cuff 24" Wide
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
KKX Drape, surgical
PUI Drape, Surgical, Exempt
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
Radiation Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Length: 42 Inch
Width: 24 Inch
CLOSE

Device Record Status

609cfe54-906e-45a0-b6b3-7bf89bb09544
September 11, 2024
5
November 14, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 00852171007186 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(404)812-9886
service@ocudrape.com
CLOSE