AccessGUDID - DEVICE: Adept Medical Antegrade IR Platform (09421905187299)

GUDID

Device Identifier (DI) Information

Brand Name: Adept Medical Antegrade IR Platform
Version or Model: AM0440
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AM0440
Company Name: ADEPT MEDICAL LIMITED

Primary DI Number: 09421905187299
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 592534619 *Terms of Use

Device Description: The Antegrade Femoral Access Platform is designed to assist in supporting equipment during the antegrade approach to the femoral artery

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:	No
Prescription Use (Rx):	No
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?
13959	Instrument table	A table used for laying out sterile surgical instruments, sutures, and other utensils/items required during an operation or intervention. It is designed to include an appropriate, e.g., stainless steel, top or surface with no crevices, screws or rivets, and most tables include telescoping pedestals for height adjustment and swivel caster bases. This table is used in the so-called "sterile area" of the operation site and in some cases may be attached to the operating table.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMN	Chair And Table, Medical

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Liquid Chemical

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b6bb6889-8ba2-443c-b224-6225a9474ae9
Public Version Date: July 05, 2019
Public Version Number: 1
DI Record Publish Date: June 27, 2019