AccessGUDID - DEVICE: MINILAP (14026704582614)

GUDID

Device Identifier (DI) Information

Brand Name: MINILAP
Version or Model: IPN002708
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PGCC300
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 14026704582614
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Clutch Grasper

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?
57956	Rigid endoscopic grasping forceps, single-use	A sterile, rigid manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument. It is typically made of metal and plastic materials and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K113597	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: 300 Millimeter

Device Record Status

Public Device Record Key: 3d186eb5-8aa6-4ed5-befe-7c4e9bd75e08
Public Version Date: May 16, 2019
Public Version Number: 5
DI Record Publish Date: September 16, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
24026704582611	6	14026704582614		In Commercial Distribution	Blister Pack
44026704582615	8	24026704582611		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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