DEVICE: CHALLENGER TI-P (04046963356019)
Device Identifier (DI) Information
CHALLENGER TI-P
PL604R
In Commercial Distribution
PL604R
Aesculap AG
PL604R
In Commercial Distribution
PL604R
Aesculap AG
CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (310 mm), diam. 5 mm, consisting of PL520R, PL522R, reusable, reposable, to be used with: PL574T, PL575SU
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
---|---|---|---|---|
35798 | Open-surgery ligation clip applier |
A hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FZP | CLIP, IMPLANTABLE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Diameter (mm) : 5.000 MM |
Device Size Text, specify: Working length (mm) : 310.000 MM |
Device Record Status
d59335e8-283a-46d2-9779-40ba241fd25f
October 21, 2021
5
September 24, 2016
October 21, 2021
5
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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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(800)282-9000
GUDID.BBMUS_Service@bbraun.com
GUDID.BBMUS_Service@bbraun.com