AccessGUDID - DEVICE: Surgical Direct (B382SD453400)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD45340
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD45340
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD453400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: Laparoscopic Trocar Incision Wound Closure & Hernia Suture Retriever, 3.0mm, 17cm, Syringe Style Handle, Pointed Tip Single Piece

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?
32617	Laparoscope system, reusable	An assembly of laparoscopes and their accessories used for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs (laparoscopy). The insertion is typically through an incision(s) made in the abdominal wall (routinely just below the umbilicus or in the near vicinity). This system is mostly used for gynaecological procedures involving the evaluation/treatment of abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, or for female sterilization. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181173	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
Length: 18 Centimeter
Outer Diameter: 3 Millimeter

Device Record Status

Public Device Record Key: b08fa809-ab0d-402b-a711-cd6d44f01610
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: April 26, 2020