AccessGUDID - DEVICE: Sutrasilk (M583S740921)

GUDID

Device Identifier (DI) Information

Brand Name: Sutrasilk
Version or Model: S74092
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VISIONARY MEDICAL SUPPLIES INC

Primary DI Number: M583S740921
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111585795 *Terms of Use

Device Description: 7-0 Suture USP / Thread Specifications: Silk, Black Braided, 18 inch (45 cm) / Needle Specifications: ST-140-9, Spatula Tip, 3/8 circle (140 degrees), length 6.6 mm, wire 0.23mm / # of needles: Double arm

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?
13910	Silk suture	A 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 device(s) [e.g., needle, passer] intended to facilitate suture application. 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GAP	Suture, Nonabsorbable, Silk

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K994177	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
Angle: 140 degree
Length: 45 Centimeter
Length: 6.6 Millimeter
Outer Diameter: 0.23 Millimeter
Device Size Text, specify: 7-0 USP

Device Record Status

Public Device Record Key: 4724047a-bff6-49ba-9e40-a62804783f18
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: September 06, 2016