DEVICE: SURGICEL FIBRILLAR (10705031003125)
Device Identifier (DI) Information
SURGICEL FIBRILLAR
1962
In Commercial Distribution
1962
Ethicon Sàrl
1962
In Commercial Distribution
1962
Ethicon Sàrl
Absorbable Hemostat (oxidized regenerated cellulose, U.S.P.)
Device Characteristics
MR Safe | |
No | |
No | |
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? |
---|---|---|---|---|
38771 | Plant polysaccharide haemostatic agent, bioabsorbable |
A bioabsorbable device derived from plant polysaccharides (e.g., starch, agar derivative, cellulose-derived) intended for topical application to a traumatic wound (e.g., abrasion, laceration, cut), ulcer, and/or surgical wound to facilitate local haemostasis; it is not dedicated to bone haemostasis. It is available in various forms (e.g., liquid, spray, foam, particles, foam pad/sponge, bandage strip, gauze pad) that can be applied directly to the wound where it remains to be absorbed by the body; it does not contain an antimicrobial agent. It may be used in combination with supplemental agents (e.g., vitamin K-dependent coagulation factors). This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LMG | Agent, absorbable hemostatic, non-collagen based |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
N12159 | 015 |
N12159 | 032 |
N12159 | 033 |
N12159 | 034 |
N12159 | 082 |
N12159 | 083 |
N12159 | 086 |
N12159 | 087 |
N12159 | 088 |
N12159 | 090 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 15 and 30 Degrees Celsius |
Storage Environment Temperature: less than 86 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
3e0d10d7-8450-4abb-a651-d75637fd7714
April 13, 2023
12
September 20, 2014
April 13, 2023
12
September 20, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20705031003122 | 10 | 10705031003125 | 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
[?]
+1(877)384-4266
xxx@xxx.xxx
xxx@xxx.xxx