DEVICE: Henry Schein (00304040006399)
Device Identifier (DI) Information
Henry Schein
1127158
In Commercial Distribution
1127158
HENRY SCHEIN, INC.
1127158
In Commercial Distribution
1127158
HENRY SCHEIN, INC.
Topical Skin Adh Flex w/Tips
Device Characteristics
MR Conditional | |
No | |
Yes | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
58779 | Dermal surgical adhesive/sealant applicator |
A sterile applicator designed to distribute surgical adhesive/sealant for topical application to the skin for various haemostatic and/or tissue bonding uses during a surgical procedure, or as treatment for traumatic or atraumatic cutaneous wounds. It typically consists of a small plastic spout with a brush tip that is attached to a vial of adhesive which is manually squeezed. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MPN | Tissue adhesive for the topical approximation of skin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 0 and 22 Degrees Celsius |
Special Storage Condition, Specify: Do not exceed 22degreeC |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 0.5 Milliliter |
Device Size Text, specify: Ampoule 0.5ml, 10/box |
Device Record Status
f6a5f581-af71-4736-824b-ca9e39a1bf3e
October 16, 2018
4
September 24, 2016
October 16, 2018
4
September 24, 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 |
---|---|---|---|---|---|
10304040006402 | 10 | 00304040006399 | 2017-10-02 | 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:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined