AccessGUDID - DEVICE: Ambler Surgical (00190660012861)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 17-165
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-165
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660012861
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Cherry supraceliac clamp, 12", angled 60º shanks, curved, atraumatic 2x3 teeth 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?
35596	Vascular clamp, reusable	A hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-retaining, scissors-like design with ring handles; the working end has blades of various designs (e.g., curved, angled, semicircular) specific for different applications. It is available in various sizes, is typically made of high-grade stainless steel, and may utilize inserts made of various materials (e.g., carbide, silicone). 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: f7987dc8-9b6f-44ce-9b91-fdb8992667e4
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016