AccessGUDID - DEVICE: Tearaway Introducer Kit (00841268105072)

GUDID

Device Identifier (DI) Information

Brand Name: Tearaway Introducer Kit
Version or Model: KIT-009-16
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KIT-009-16
Company Name: GALT MEDICAL CORP.

Primary DI Number: 00841268105072
Issuing Agency: GS1
Commercial Distribution End Date: March 05, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 943156836 *Terms of Use

Device Description: Tearaway Introducer Kit

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?
58865	Vascular catheter introduction set, nonimplantable	A collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OFL	Percutaneous Sheath Introducer Kit

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: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Catheter Gauge: 15 French

Device Record Status

Public Device Record Key: 557987dc-0dfc-41aa-9c06-63822f675e27
Public Version Date: March 20, 2024
Public Version Number: 5
DI Record Publish Date: February 06, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
20841268105076	50	10841268105079	2021-03-05	Not in Commercial Distribution	Shipper Box
10841268105079	5	00841268105072	2021-03-05	Not in Commercial Distribution	Shelf Box