AccessGUDID - DEVICE: Ambler Surgical (00190660014865)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 17-532
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-532
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660014865
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: DeBakey-Derra anastomosis clamp, 6 1/2", large, angled, 2.5cm long x 15.0mm deep atraumatic jaws, ring handle

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:	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?
43142	Vascular anastomosis clamp	A surgical instrument used to perform a vascular anastamosis (surgical communication between two or more veins or arteries) by compressing the vessels to ensure haemostasis (arrest or prevention of bleeding) before the procedure. It is typically self-retaining and has a scissors-like design with ring handles and blades of various designs (e.g., curved, angled, or semicircular) at the working end, or it may be designed with levers that are locked into position at the site of intervention. It is typically made of high-grade stainless steel and may utilize carbide inserts; it is available in various sizes for different applications. This is a reusable device.	Obsolete	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 [?]
Moist Heat or Steam Sterilization

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: 10b94f03-0325-4ffb-9819-f48d81c1556a
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016