DEVICE: Xguard (08054301890428)

Download: XML | JSON
Print
Device Record History
View all sections | Close all sections

Device Identifier (DI) Information
Xguard
RR310
In Commercial Distribution
RR310
EMERSON & CO SRL
08054301890428
GS1

1
630558211 *Terms of Use
Radiation Reducing Glove
CLOSE

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
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
IWP Radiographic Protective Glove
CLOSE

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

Sterilization
Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: in a dry place away from light and heat sources (below 35°)
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status
b45c9b21-80fc-478e-a128-076a6b7709e1
April 16, 2018
1
March 16, 2018
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
08054301891166 3 08054301890428 In Commercial Distribution
CLOSE

Secondary DI

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

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE