DEVICE: Strong Manufacturers (00850005354710)
Device Identifier (DI) Information
Strong Manufacturers
5313
In Commercial Distribution
5313
Strong Medical Partners LLC
5313
In Commercial Distribution
5313
Strong Medical Partners LLC
Earloop Surgical Mask, blue, contains forming nosepiece, free of metal components, MR safe, ASTM F2100 Level 3
Device Characteristics
MR Safe | |
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? |
---|---|---|---|---|
66199 | Surgical/medical face mask, non-antimicrobial, single-use |
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FXX | Mask, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Standard storage/handling recommended (i.e. room temperature) |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9d8a3e96-416d-4357-84df-22be50041afc
December 23, 2022
2
January 21, 2021
December 23, 2022
2
January 21, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10850005354717 | 300 | 00850005354710 | In Commercial Distribution | 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
[?]
716-507-4476
info@strongmanufacturers.com
info@strongmanufacturers.com