DEVICE: Exact Medical Manufacturing, Inc. (00852205007922)
Device Identifier (DI) Information
Exact Medical Manufacturing, Inc.
EP5513
Not in Commercial Distribution
EP5513
EXACT MEDICAL MANUFACTURING, INC.
EP5513
Not in Commercial Distribution
EP5513
EXACT MEDICAL MANUFACTURING, INC.
Microscope Drape, Leica 137x381cm – 54” x 150”
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
Yes | |
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 |
---|---|
HMW | Drape, Microscope, Ophthalmic |
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 |
---|
No Device Sizes |
Device Record Status
53dc9814-5461-4bae-bcac-98ea2a8584a5
October 03, 2024
3
October 24, 2017
October 03, 2024
3
October 24, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
00852205007946 | 1 | 00852205007939 | 2024-10-02 | Not in Commercial Distribution | Case |
00852205007939 | 16 | 00852205007922 | 2024-10-02 | Not in Commercial Distribution | Inner Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
716-681-0866
rdean@exactmm.com
rdean@exactmm.com