DEVICE: AngioSystems Drape (00081661102190)
Device Identifier (DI) Information
AngioSystems Drape
9260-12
In Commercial Distribution
ANGIOSYSTEMS, INCORPORATED
9260-12
In Commercial Distribution
ANGIOSYSTEMS, INCORPORATED
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
No | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Angiographic drape | A flexible, protective covering made of natural or synthetic materials, or both, designed to be used on patients during an angiographic procedure to control microbial and substance (e.g., blood, contrast material) contamination of the patient entry field. It may be specific for brachial or femoral procedures, and may include a window(s) for viewing and/or a trough to collect spilled substances. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
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KKX | Drape, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3db78f6a-c9ce-4d14-abd8-f9fe491cb8dd
March 29, 2018
2
August 30, 2016
March 29, 2018
2
August 30, 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 |
---|---|---|---|---|---|
0081661102191 | 20 | 00081661102190 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
No Customer Contact currently defined