AccessGUDID - DEVICE: Angio-Seal™ (05415067002877)

GUDID

Device Identifier (DI) Information

Brand Name: Angio-Seal™
Version or Model: STS Plus
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 610121
Company Name: ST. JUDE MEDICAL CARDIOVASCULAR DIVISION

Primary DI Number: 05415067002877
Issuing Agency: GS1
Commercial Distribution End Date: April 20, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 040960379 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
60710	Femoral artery closure plug/patch, collagen	An implantable, bioabsorbable device designed for haemostasis/closure of a puncture site, through pressure/compression, on a patient having undergone femoral artery catheterization; it is intended as an alternative to manual compression or surgical techniques to reduce the time to haemostasis. It consists of an animal-derived collagen plug that is implanted using an included delivery device (e.g., guidewire, hand-held delivery unit) onto the extravascular surface of the femoral artery access site (top of arteriotomy site), and may be held in place with an included synthetic, bioabsorbable patch/anchor/suture to achieve haemostasis.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MGB	DEVICE, HEMOSTASIS, VASCULAR

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
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Special Storage Condition, Specify: Keep dry and Keep away from sunlight. Do not use if temperature indicator dot has changed from light gray to dark gray or black.

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 8 French

Device Record Status

Public Device Record Key: dfd47789-faf5-4ebd-980f-0da24df6903a
Public Version Date: February 05, 2021
Public Version Number: 5
DI Record Publish Date: October 24, 2014