AccessGUDID - DEVICE: WECK (14026704933300)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN930187
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AE05ML
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704933300
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: AUTOMATIC END0SCOPIC 5 MEDIUM LARGE

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:	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?
56711	Ligation clip, synthetic polymer, non-bioabsorbable	A non-metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel or a tissue bundle for permanent occlusion. It is typically made of plastic materials [e.g., polyoxymethylene (POM), commonly known as Delrin] and may be designed with a self-locking catch. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries, but is usually not intended for fallopian tube occlusion. Its non-metallic design makes it more compatible with radiological imaging than metallic clips. A dedicated, disposable clip applier may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
FZP	Clip, implantable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K230480	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
Length: 35 Centimeter

Device Record Status

Public Device Record Key: 96ecf6d4-3987-49db-afe9-f1cb9739f347
Public Version Date: November 25, 2024
Public Version Number: 1
DI Record Publish Date: November 15, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
44026704933301	6	34026704933304	In Commercial Distribution	Case
34026704933304	3	24026704933307	In Commercial Distribution	Box
24026704933307	1	14026704933300	In Commercial Distribution	Box

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(919)544-8000
Email: CS@TELEFLEX.COM

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