DEVICE: AESCULAP (04046963356033)

Device Identifier (DI) Information

AESCULAP
PL608R
In Commercial Distribution
PL608R
Aesculap AG
04046963356033
GS1

1
315018218 *Terms of Use
CHALLENGER TI-P Clip Applier Forceps, pneumatic, multi-fire, (260 mm), diam. 10 mm, consisting of PL520R, PL538R, reusable, reposable, to be used with: PL575SU, PL579T
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Ligation clip applier A hand-held manual surgical instrument designed to apply small atraumatic clips 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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FDA Product Code

[?]
Product Code Product Code Name
FZP CLIP, IMPLANTABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: Working length (mm) : 260.000 MM
Device Size Text, specify: Diameter (mm) : 10.000 MM
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Device Record Status

3464fb44-96b4-4ed8-b3ae-06e175550b12
March 29, 2018
2
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
+1(800)282-9000
GUDID.BBMUS_Service@bbraun.com
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