AccessGUDID - DEVICE: ABSORB GT1 (08717648213021)

GUDID

Device Identifier (DI) Information

Brand Name: ABSORB GT1
Version or Model: 1235300-12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1235300-12
Company Name: ABBOTT VASCULAR INC.

Primary DI Number: 08717648213021
Issuing Agency: GS1
Commercial Distribution End Date: March 14, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 964569052 *Terms of Use

Device Description: Absorb GT1 Bioresorbable Vascular Scaffold System 3.00 mm x 12 mm / Rapid-Exchange

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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:	Yes
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?
56304	Drug-eluting coronary artery stent, fully-bioabsorbable	A bioabsorbable tubular or coil-shaped device with a drug coating intended to be implanted, via a delivery catheter, into a de novo or restenotic native coronary artery during a percutaneous coronary intervention (PCI) to temporarily maintain its patency, typically in patients with symptomatic atherosclerotic heart disease. The drug is intended to release slowly to inhibit restenosis by reducing vessel smooth muscle cell proliferation. The device is made of a material capable of being degraded and absorbed by body tissues (e.g., bioabsorbable polymer) and is designed to remain in the vessel to provide support for the stenosed lesion until it degrades.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
PNY	Absorbable coronary drug-eluting stent

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
Handling Environment Temperature: between -20 and 30 Degrees Celsius
Storage Environment Temperature: between -20 and 25 Degrees Celsius
Special Storage Condition, Specify: Store at or below 25 degrees C; excursions permitted to 30 degrees C. Check temperature indicator prior to use of product.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1c64ac56-0a0c-4746-9995-b58fae6fa721
Public Version Date: April 16, 2024
Public Version Number: 5
DI Record Publish Date: July 15, 2016