AccessGUDID - DEVICE: Blunt Dissector - 3 pack (05051223004226)

GUDID

Device Identifier (DI) Information

Brand Name: Blunt Dissector - 3 pack
Version or Model: PS3885
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PS3885
Company Name: PURPLE SURGICAL INTERNATIONAL LIMITED

Primary DI Number: 05051223004226
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 239403863 *Terms of Use

Device Description: The Blunt Dissector is used during laparoscopic procedures to provide a means for the safe atraumatic manipulation and dissection of tissue during abdominal investigation.

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:	Yes
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?
13698	Dissection sponge	A sterile device intended to be used for blunt tissue dissection during a surgical procedure (e.g., from gross dissection to delicate neurological surgery). It typically consists of a small sponge made of hard but absorbent material (e.g., cotton twill, gauze, rayon) and frequently including an x-ray radiopaque element; some types include a hole in the centre to facilitate manipulation with forceps. It is available in a wide range of sizes and shapes (e.g., rosebud, peanut, cherry, round, Kittner). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDI	Dissector, Surgical, 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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 400 Millimeter

Device Record Status

Public Device Record Key: 6de230c6-010f-4e43-b429-2529d34bf72f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 17, 2016