AccessGUDID - DEVICE: ANGIO-SEAL (00389701011868)

GUDID

Device Identifier (DI) Information

Brand Name: ANGIO-SEAL
Version or Model: 610119
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 610119
Company Name: TERUMO MEDICAL CORPORATION

Primary DI Number: 00389701011868
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 962520628 *Terms of Use

Device Description: ANGIO-SEAL STS Plus Vascular Closure Device

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

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 6 French

Device Record Status

Public Device Record Key: b64034db-1c11-48ba-8f8c-ecfaf8e8f0e6
Public Version Date: March 21, 2022
Public Version Number: 7
DI Record Publish Date: April 20, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30389701011869	5	00389701011868	2020-12-31	Not in Commercial Distribution	Shelfbox
50389701011863	2	30389701011869	2020-12-31	Not in Commercial Distribution	Carton