DEVICE: Batrik Saveface (00690521015296)
Device Identifier (DI) Information
Batrik Saveface
SF-100
In Commercial Distribution
SF-100
Batrik Medical Manufacturing Inc
SF-100
In Commercial Distribution
SF-100
Batrik Medical Manufacturing Inc
Saveface Shields, 9" (23 cm) Length
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
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? |
---|---|---|---|---|
11961 | Face splash shield, single-use |
A clear, transparent guard intended to provide full face cover, to protect (shield) the healthcare worker from blood and other body fluid splashes while performing a clinical or laboratory procedure. It is commonly known as a splash shield. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LYU | Accessory, Surgical Apparel |
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: Store at ambient temperature |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
617888d9-16a4-41dc-965c-1878b8829104
October 05, 2020
1
September 25, 2020
October 05, 2020
1
September 25, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
514-631-7988
info@surgmed.com
info@surgmed.com