AccessGUDID - DEVICE: EUROPCLIP Applier (04251852735947)

GUDID

Device Identifier (DI) Information

Brand Name: EUROPCLIP Applier
Version or Model: 13-1610AS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 13-1610AS
Company Name: Ackermann Instrumente GmbH

Primary DI Number: 04251852735947
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315121009 *Terms of Use

Device Description: Endoscopic Clip Applier for Europclips, Light blue (M), ring handle, 330 mm, Ø10,0 mm

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?
65058	Endoscopic surgical ligation clip applier, reusable	A hand-held manual surgical instrument intended to be used during an endoscopic (e.g., laparoscopic) surgical procedure 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). It is neither designed to apply aneurysm clips nor gastrointestinal clips. It typically includes distal jaws, a slender shaft, and a proximal handle (e.g., trigger-like). The ligation clips are not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBT	Applier, Hemostatic Clip

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
No Device Sizes

Device Record Status

Public Device Record Key: f6afd811-5bf6-46ca-be57-d88cad3bb75b
Public Version Date: February 11, 2022
Public Version Number: 1
DI Record Publish Date: February 03, 2022