AccessGUDID - DEVICE: AROSuture Sterile (10818245020533)

GUDID

Device Identifier (DI) Information

Brand Name: AROSuture Sterile
Version or Model: SP15A04H-45
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SP15A04H-45
Company Name: AROS SURGICAL INSTRUMENTS CORPORATION

Primary DI Number: 10818245020533
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 883777989 *Terms of Use

Device Description: AROSuture-Sterile 4-0, 1/2 circle,13mm, Spatula reverse cutting, 18 inches, Box/12

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?
47068	Vascular clamp, single-use	A sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAR	Suture, nonabsorbable, synthetic, polyamide

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Needle Length 15mm
Device Size Text, specify: Thread Diameter 0.15mm

Device Record Status

Public Device Record Key: 6c1f5534-295a-4399-9b9c-2d96de392bfc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: November 18, 2016