AccessGUDID - DEVICE: MANI Sutures Nylon (04546951402471)

GUDID

Device Identifier (DI) Information

Brand Name: MANI Sutures Nylon
Version or Model: 2806
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2806
Company Name: MANI, INC.

Primary DI Number: 04546951402471
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690622428 *Terms of Use

Device Description: MANI Ophthalmic Sutures

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

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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
Nylon suture, monofilament	A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress; it can be removed from the tissue once wound healing occurs or allowed to remain in the tissue where it is gradually encapsulated by fibrous connective tissue. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Nylon suture, monofilament

A sterile, single-strand (monofilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress; it can be removed from the tissue once wound healing occurs or allowed to remain in the tissue where it is gradually encapsulated by fibrous connective tissue. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
GAR	Suture, Nonabsorbable, Synthetic, Polyamide

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053637	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
Device Size Text, specify: Needle Length 6.0mm
Device Size Text, specify: Suture Length 30cm

Device Record Status

Public Device Record Key: aa292c26-3373-4f4f-bcd3-ab938f49621a
Public Version Date: July 09, 2018
Public Version Number: 3
DI Record Publish Date: June 04, 2016