AccessGUDID - DEVICE: Ambler Surgical (00190660014346)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 17-464
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-464
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660014346
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: DeBakey coarctation clamp, 9", angled shanks, straight, 5.5cm long 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?
35594	Aortic coarctation clamp	A hand-held manual surgical instrument designed for the temporary, atraumatic compression of the section of aorta effected by coarctation (i.e., a congenital narrowing of the aorta in the vicinity of the insertion of the ductus arteriosus). It typically has a self-retaining, scissors-like design with ring handles and is made of high-grade stainless steel; it may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and has serrated blades that are either straight or curved. The serrated region has a central, non-serrated trough running its length to prevent trauma to the enclosed vessel. 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: 25715ddb-ea23-46a4-88f4-ebe8cb39750f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016