AccessGUDID - DEVICE: ICLED™ Surgical Suture System (00861810000303)

GUDID

Device Identifier (DI) Information

Brand Name: ICLED™ Surgical Suture System
Version or Model: 70001
Catalog Number:
Company Name: IMPLICIT CARE LLC

Primary DI Number: 00861810000303
Issuing Agency: GS1
Device Count: 1

Device Description: The device designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and elevation of subdermis/underlying muscle procedure. All components are sterile and intended for single use only.

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):	No
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Polyester suture	A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyester (a polymer of polyethylene terephthalate) fibres, that may be coated (e.g., with polybutilate/silicone), intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may also include an attached disposable needle or preloaded pledget for enhanced support. It is commonly used for vessel anastomosis and the placement of prosthetic materials, and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it elicits minimal tissue reaction and lasts indefinitely in the body. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Polyester suture

A sterile, multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of polyester (a polymer of polyethylene terephthalate) fibres, that may be coated (e.g., with polybutilate/silicone), intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may also include an attached disposable needle or preloaded pledget for enhanced support. It is commonly used for vessel anastomosis and the placement of prosthetic materials, and provides temporary wound support until the wound sufficiently heals to withstand normal stress; it elicits minimal tissue reaction and lasts indefinitely in the body. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene

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
No Device Sizes

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: August 17, 2016
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

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

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DEVICE: ICLED™ Surgical Suture System (00861810000303)