AccessGUDID - DEVICE: Aligned Medical Solutions (B098CCR600460)

GUDID

Device Identifier (DI) Information

Brand Name: Aligned Medical Solutions
Version or Model: CCR60046
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CCR60046
Company Name: Aligned Medical Solutions

Primary DI Number: B098CCR600460
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 106580145 *Terms of Use

Device Description: Laparotomy Pack V

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:	Yes
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?
44096	Laparoscopic surgical procedure kit, non-medicated, single-use	A collection of various sterile laparoscopic and surgical instruments (e.g., access cannulae, forceps), dressings, and additional materials intended to be used specifically to perform a laparoscopic surgical procedure. It does not contain pharmaceuticals. It may be referred to as a procedure tray. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FDE	laparoscopy kit

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 830b8415-2a2b-409e-bbfa-d05f58b54b7b
Public Version Date: December 17, 2018
Public Version Number: 1
DI Record Publish Date: November 14, 2018