AccessGUDID - DEVICE: MANI Sutures Silk (04546951402631)

GUDID

Device Identifier (DI) Information

Brand Name: MANI Sutures Silk
Version or Model: 3305S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3305S
Company Name: MANI, INC.

Primary DI Number: 04546951402631
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
Silk suture, sterile	A sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 disposable needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

GMDN Preferred Term Name

GMDN Definition

Silk suture, sterile

A sterile, natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) 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 disposable needle. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.

FDA Product Code

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Product Code	Product Code Name
GAP	Suture, Nonabsorbable, Silk

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K053638	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 11.0mm
Device Size Text, specify: Suture Length 45cm

Device Record Status

Public Device Record Key: d045ff7b-0dbc-47ca-8ad8-76ab3c45cd20
Public Version Date: July 09, 2018
Public Version Number: 3
DI Record Publish Date: June 04, 2016