AccessGUDID - DEVICE: Sutrazorb (M583A84082TP1)

GUDID

Device Identifier (DI) Information

Brand Name: Sutrazorb
Version or Model: A84082TP
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VISIONARY MEDICAL SUPPLIES INC

Primary DI Number: M583A84082TP1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 111585795 *Terms of Use

Device Description: 8-0 Suture USP / Thread Specifications: PGA, 5 inch (13 cm) / Needle Specifications: TP-140-8, Taper Point, 3/8 (140 degrees), length 6.5mm, wire diameter 0.20 mm / # 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?
13908	Polyglycolic acid suture	A sterile, typically multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polymerization of polyglycolic acid (PGA) that is intended to join (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; it may be coated with a material such as polycaprolactone or uncoated. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Keep away from Moisture, chemicals, oxides, and direct heat.
Storage Environment Temperature: less than 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 0.20 Millimeter
Angle: 140 degree
Length: 6.5 Millimeter
Length: 13 Centimeter
Device Size Text, specify: 8-0 USP

Device Record Status

Public Device Record Key: c3b2ae05-5e22-4c24-bb0b-590c3c3f980f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 13, 2016