DEVICE: PINK RIBBON LATEX PF EXAM PNK XS (D766432221)
Device Identifier (DI) Information
PINK RIBBON LATEX PF EXAM PNK XS
43222
In Commercial Distribution
43222
Smarthealth, Inc.
43222
In Commercial Distribution
43222
Smarthealth, Inc.
GLV PINK RIBBON LATEX PF EXAM PNK XS*100
Device Characteristics
Labeling does not contain MRI Safety Information | |
Yes | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
47172 | Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial |
A device made of Hevea natural rubber latex (NRL) intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYY | Latex Patient Examination Glove |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: less than 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: XS |
Device Record Status
77e5c2f9-264a-4dd4-bba1-bc8d903bfd6f
July 25, 2023
1
July 17, 2023
July 25, 2023
1
July 17, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
D766432222 | 10 | D766432221 | In Commercial Distribution | case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
D766432220
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-800-522-0800
info@smartpractice.com
info@smartpractice.com