DEVICE: ComforTen® 30-hole covered tray (00365044000059)
Device Identifier (DI) Information
ComforTen® 30-hole covered tray
8406ZA
In Commercial Distribution
8406ZA
Jubilant Hollisterstier LLC
8406ZA
In Commercial Distribution
8406ZA
Jubilant Hollisterstier LLC
30 hole test tray
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
45539 | Allergy testing lancet |
A sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LDH | System, Delivery, Allergen And Vaccine |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K953939 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
c3ea3de7-03a3-485b-84ba-beabf6b9cf8d
November 25, 2024
1
November 15, 2024
November 25, 2024
1
November 15, 2024
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
[?]
800.495.7437
HollisterStier@jubl.com
HollisterStier@jubl.com