AccessGUDID - DEVICE: Heartline MIS Bulldog Aortic Clamp (00192896119376)

GUDID

Device Identifier (DI) Information

Brand Name: Heartline MIS Bulldog Aortic Clamp
Version or Model: 2800-7903
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2800-7903
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: 00192896119376
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: Heartline MIS Bulldog Aortic Clamp Straight

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:	No
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?
62470	Surgical bulldog clamp, reusable	A manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of high-grade stainless steel. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DXC	CLAMP, VASCULAR

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K092544	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 135 Millimeter

Device Record Status

Public Device Record Key: ac312597-aeb4-4eca-8197-ad15608bd81a
Public Version Date: September 12, 2024
Public Version Number: 1
DI Record Publish Date: September 04, 2024