AccessGUDID - DEVICE: Ambler Surgical (00190660049669)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: 28-702
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 28-702
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660049669
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: DeBakey needle pulling tissue forceps, 6", delicate, straight, 2x4 teeth, 1.5mm TC tips with serrated platform, flat 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?
11785	Intestinal forceps	A hand-held manual surgical instrument designed for the atraumatic holding/grasping and/or compression of intestinal structures, tissues, and some organs during a surgical procedure. It typically has two main designs: 1) a self-retaining, scissors-like design with ring handles; or 2) a large tweezers-like design with straight blades that are conjoined at the proximal end. It is available in various sizes and the working end can terminate in a variety of blade designs (e.g., loops or triangles that have parallel grooves or serrations for grip, or inward curved profiles to grasp over or around). It is made of high-grade stainless steel. 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: e2e372a3-d45f-4d7c-9e74-3f1855fe0a52
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 29, 2016