AccessGUDID - DEVICE: AESCULAP (04046963356019)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: PL604R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL604R
Company Name: Aesculap AG

Primary DI Number: 04046963356019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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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.

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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter (mm) : 5.000 MM
Device Size Text, specify: Working length (mm) : 310.000 MM

Device Record Status

Public Device Record Key: d59335e8-283a-46d2-9779-40ba241fd25f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016