AccessGUDID - DEVICE: Integra (00650551001058)

GUDID

Device Identifier (DI) Information

Brand Name: Integra
Version or Model: 3610-625-2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PMT CORPORATION

Primary DI Number: 00650551001058
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 039576871 *Terms of Use

Device Description: TE, RECTANGLE SHAPE, 2-STAGE, SMOOTH SURFACE, MICRO REMOTE PORT TUBING, 3X7CM, 102CC FILL, 6CM PROJECTION

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?
45188	Mechanical atherectomy system catheter, coronary/peripheral	A sterile, flexible tube (catheter) intended to be percutaneously introduced for the intraluminal mechanical disruption of atheroma plaque from the walls of both coronary and peripheral arteries (or vein grafts). It has a power-driven cutting or abrasive head for slicing/grinding the atheroma into fragments small enough to be aspirated or absorbed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LCJ	Expander, Skin, Inflatable

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K845036	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 24e8f085-e4c5-4b35-9946-fd93f68f7cd3
Public Version Date: July 06, 2021
Public Version Number: 1
DI Record Publish Date: June 28, 2021