AccessGUDID - DEVICE: Alleset (16931918133959)

GUDID

Device Identifier (DI) Information

Brand Name: Alleset
Version or Model: PRD3680
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: GRI Medical & Electronic Technology Co., Ltd.

Primary DI Number: 16931918133959
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 12
Labeler D-U-N-S® Number*: 679894738 *Terms of Use

Device Description: Mattress cover_Flat_80in_one inner label_12PCS

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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":	Yes
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?
65175	Operating room turnover kit	A collection of devices intended to be used to efficiently clean and prepare an operating room (OR) for a subsequent surgical procedure. It typically includes patient oriented items such as absorbent covers/drapes for the operating table and patient positioners (e.g., headrest), operating room cleaning items such as cleaning mop heads and pads, and refuse containment items such as surgical waste and biohazard bags/buckets. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FMW	Cover, Mattress (Medical Purposes)

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: 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: 852df6ba-72a8-4e7a-9d36-f8babbe0cc0f
Public Version Date: December 01, 2022
Public Version Number: 1
DI Record Publish Date: November 23, 2022