AccessGUDID - DEVICE: WECK (14026704667472)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN039776
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AE10LG
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704667472
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use
Previous DI: 14026704553133

Device Description: AUTOMATIC ENDOSCOPIC 10 LARGE

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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?
65721	Endoscopic surgical ligation clip applier, single-use	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 single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZP	CLIP, IMPLANTABLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K161758	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 10 Millimeter
Length: 35 Centimeter

Device Record Status

Public Device Record Key: 399a0c7f-4e9b-46ad-98be-f033bdd99bcd
Public Version Date: January 16, 2025
Public Version Number: 3
DI Record Publish Date: July 01, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
44026704667473	6	34026704667476	In Commercial Distribution	Case
34026704667476	3	24026704667479	In Commercial Distribution	Box
24026704667479	1	14026704667472	In Commercial Distribution	Box