AccessGUDID - DEVICE: Ambler Surgical (00190660066291)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Mixter dissecting forceps
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 97-270
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660066291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Mixter dissecting forceps, rotatable, double-action, 10.0mm diameter, 330.0mm working length, 90 degrees angled 10.0mm long tips, serrated jaws, outer sheath, carbon fiber ring handle, HF connection

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?
62667	Laparoscopic tissue manipulation forceps/working-channel	A rigid, hand-held manual surgical instrument designed to be introduced through a laparoscope/laparoscopic port for: 1) atraumatic grasping/clamping of soft tissues (e.g., gallbladder); and 2) access adjacent to the site of clamping (e.g., during laparoscopic cholangiography). It is a hand-held device with proximal handles, a rigid long slender shaft with a built-in working-channel, and distal grasping blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEN	FORCEPS, GENERAL & PLASTIC SURGERY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 1b0bb242-60e6-41db-9ea7-349d2d819803
Public Version Date: January 15, 2021
Public Version Number: 1
DI Record Publish Date: January 07, 2021