AccessGUDID - DEVICE: AESCULAP (04038653241156)

GUDID

Device Identifier (DI) Information

Brand Name: AESCULAP
Version or Model: PL538R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PL538R
Company Name: Aesculap AG

Primary DI Number: 04038653241156
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315018218 *Terms of Use

Device Description: CHALLENGER TI Clip Applier (Shaft Only), multi-fire, (260 mm), diam. 10 mm, to be used with: PL510R, PL569T

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

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OCW	Endoscopic tissue approximation device

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) : 10.000 MM
Device Size Text, specify: Working length (mm) : 260.000 MM

Device Record Status

Public Device Record Key: 43c03b6d-390d-4f9c-a8d0-68817f09299d
Public Version Date: October 23, 2024
Public Version Number: 4
DI Record Publish Date: September 23, 2016