DEVICE: Xguard (08054301890237)

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Device Record History
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Device Identifier (DI) Information
Xguard
RR160
In Commercial Distribution
RR160
EMERSON & CO SRL
08054301890237
GS1

1
630558211 *Terms of Use
Radiation Reducing Glove
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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?
38364 Radiation shielding glove
A personal protective device used to shield the entire hand or hands of an individual (i.e., the operator or other attending person) from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Each finger is shielded individually. When used in diagnostic x-ray and nuclear medicine, it typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material. The glove offers radiation protection from all directions to the fingers, top and bottom of the hand. Some provide an additional physical barrier protection from liquid radioactive materials and body fluids.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
LZC Patient Examination Glove, Specialty
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: dry place away from light and heat sources ( below 35° C)
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
a0090a10-dbec-4005-a2b1-d22f23607b23
April 16, 2018
1
March 16, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
08054301890978 5 08054301890237 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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