AccessGUDID - DEVICE: Ambler Surgical (00190660012816)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 17-155
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 17-155
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660012816
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Castaneda multi-purpose clamp, 4 3/4", curved shanks, spoon curved, 2.4cm long x 8.0mm deep serrated 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?
15881	Neonatal/paediatric vascular clamp	A hand-held manual surgical instrument designed to compress a blood vessel (a vein or an artery) during neonatal/paediatric surgery for haemostasis (arrest or prevention of bleeding). It typically has a self-retaining, scissors-like design with ring handles and very delicate blades at the working end. It is made of high-grade stainless steel and may utilize inserts made of various materials (e.g., carbide). It is available in various sizes and the blades at the working end can have a wide variety of designs (e.g., curved, angled, semicircular) specific to different applications (e.g., for small vessels, anastomoses, aorta). 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: 2bc8daf1-397f-4f89-bd6f-5ca137d5c80f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016