AccessGUDID - DEVICE: ARROW (10801902121322)

GUDID

Device Identifier (DI) Information

Brand Name: ARROW
Version or Model: IPN036258
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ST-09807
Company Name: TELEFLEX INCORPORATED

Primary DI Number: 10801902121322
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002348191 *Terms of Use

Device Description: Cath-Gard(R) Catheter Contamination Shield with Tuohy-Borst Adapter on Proximal End for use with 7 and 7.5 Fr. Catheters and Arrow Percutaneous Sheath Introducer Systems

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
46505	Surgical instrument guard, single-use, sterile	A sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DQO	CATHETER, INTRAVASCULAR, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K895268	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: 616a1cd6-b4f1-4301-8b00-53b80aa8de0e
Public Version Date: December 22, 2021
Public Version Number: 7
DI Record Publish Date: September 16, 2016