AccessGUDID - DEVICE: N/A (00885825011710)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 408310
Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.

Primary DI Number: 00885825011710
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 020198912 *Terms of Use

Device Description: Small Curl Catheter Introducer Sheath 11.5 OD/8.5F ID, 8.5F dilator, 94cm dilator length, 91 lumen length, 180cm guidewire length

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?
61808	Vascular guide-catheter, reprocessed	A sterile, flexible, single-lumen tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter or lead (e.g., pacing lead, balloon dilatation catheter) through its lumen, within the vascular system. It may be rigid or flexible, non-steerable or steerable, and the distal section of the tube can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended for infusion, and is not a microcatheter (i.e., not intended to access superselective small vessels). It may include a disposable percutaneous introduction set. This is a previously used single-use device that has been processed for an additional single-use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYB	INTRODUCER, CATHETER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K123334	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
Device Size Text, specify: Diameter: 0.032 Inch
Length: 71.0 Centimeter

Device Record Status

Public Device Record Key: 0329c8a6-c699-40df-8b34-5766c9cd79ab
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016