AccessGUDID - DEVICE: WECK (14026704553133)

GUDID

Device Identifier (DI) Information

Brand Name: WECK
Version or Model: IPN010798
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AE10LG
Company Name: TELEFLEX INCORPORATED

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

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?
58040	Laparoscopic clip applier	A sterile, rigid device designed to perform through a compatible laparoscopic instrument (e.g., a laparoscopic sleeve) for the application of an implantable clip(s), to achieve ligation/occlusion during transection or for radiographic marking. It typically consists of an insertion sheath, a mechanism at the distal end for applying the clips, an integral cassette containing the surgical or ligation clips, and a control handle at the proximal end for firing the clips into the target tissue. This is a single-use device.	Obsolete	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
Length: 35 Centimeter
Outer Diameter: 10 Millimeter

Device Record Status

Public Device Record Key: bffd2c48-1793-42c0-b2db-71cba2a29689
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 12, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
44026704553134	6	24026704553130	In Commercial Distribution	Case
24026704553130	3	04026704553136	In Commercial Distribution	Box
04026704553136	1	14026704553133	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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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