AccessGUDID - DEVICE: LAZIC (04250603738206)

GUDID

Device Identifier (DI) Information

Brand Name: LAZIC
Version or Model: 45.028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 45.028
Company Name: Peter Lazic GmbH

Primary DI Number: 04250603738206
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 327681359 *Terms of Use

Device Description: STORAGE TRAY FOR 144 L-ANEURYSM CLIPS AND CLIP-APPLIERS / INSTRUMENTS, ALU-CASE WITH 5 PPSU BOXES FOR CLIPS 540x253x95 MM

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?
16349	Instrument transport trolley system	A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LRP	Tray, Surgical

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: 66f60c17-7b6e-4fb8-854e-fc8921d2a0d1
Public Version Date: July 08, 2021
Public Version Number: 2
DI Record Publish Date: December 08, 2020