DEVICE: Critical Cover (10817583020571)
Device Identifier (DI) Information
Critical Cover
BL6001CC
Not in Commercial Distribution
BL6001CC
Alpha Pro Tech, Inc.
BL6001CC
Not in Commercial Distribution
BL6001CC
Alpha Pro Tech, Inc.
TIE STRING MASK, BLUE
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
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? |
---|---|---|---|---|
43315 | Surgical hood |
A non-sterile head covering designed as a top with elongated sides and back with a front opening for the face to be used by surgical staff to cover their hair and facial hair (beards) in order to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material. It is typically made of soft, disposable materials. 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 |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
92f692a7-9d80-41c4-a8f2-8b5a79c724be
June 12, 2025
8
November 03, 2016
June 12, 2025
8
November 03, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20817583020578 | 6 | 10817583020571 | 2023-04-19 | Not in Commercial Distribution | CASE |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00817583020574
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1-520-281-0127
XX@XX.XX
XX@XX.XX