AccessGUDID - DEVICE: Simelo (06977153531016)

GUDID

Device Identifier (DI) Information

Brand Name: Simelo
Version or Model: 50mm×200m
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: WEIHAI XINGTAI PACKAGING PRODUCTS CO.,LTD.

Primary DI Number: 06977153531016
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 541834823 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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):	No
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?
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRG	Wrap, Sterilization

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K193561	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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
No Device Sizes

Device Record Status

Public Device Record Key: 8165735b-fdaf-4e51-a0d6-39ab8a7cf284
Public Version Date: February 21, 2025
Public Version Number: 2
DI Record Publish Date: September 12, 2024