AccessGUDID - DEVICE: Arm Needle holder (03665772000060)

GUDID

Device Identifier (DI) Information

Brand Name: Arm Needle holder
Version or Model: B-1301
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DEX SURGICAL

Primary DI Number: 03665772000060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 268845728 *Terms of Use

Device Description: The arm needle holder is a reusable (40 uses) endoscopic instrument. It is connected to the control handle and is used with the single-use Protection sleeve (ref. 2090-MDS). Each Arm is composed of a shaft, a connection cover and an articulated instrument followed by the needle holder tip that provides distal mobility. 1. Tilting the tip with respect to the axis of the shaft 2. Rotation of the tip around its own axis 3. Opening-closing the tip/needle holder

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?
58137	Endoscopic electromechanical surgical system	An assembly of mains electricity (AC-powered) electromechanical devices designed to be used to perform an endoscopic surgical procedure (e.g., laparoscopy) via hand-held rigid endoscopic instruments that have motor-driven articulating and mechanically-operated tips intended to facilitate surgical dexterity. It typically consists of a control unit that provides power via connecting cables to individual handpieces (handles) and several interchangeable endoscopic instruments with tip articulation (e.g., roll, yaw) for performing tissue manipulation, ligation, suturing, and cutting. The system is connected to a visual display unit (VDU) and is typically mounted on a trolley (cart) for mobility.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	Electrosurgical, Cutting & Coagulation & Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191878	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: 0ac5aedf-ef8d-4a83-beee-19ad857adb19
Public Version Date: May 16, 2022
Public Version Number: 1
DI Record Publish Date: May 06, 2022