Device
Armboard cover w/ tape_SMS_38cmx80cm_Non-sterile_3870/cs
Manufacturer
GRI Medical & Electronic Technology Co., Ltd.
GRI Medical & Electronic Technology Co., Ltd.
Model: 60300694
DI: 16931918186184
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-29
Current Version: 2026-05-07
Description
Armboard cover w/ tape_SMS_38cmx80cm_Non-sterile_3870/cs
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3328ba5d-11bb-4259-9455-7012c27d9e5b
Distribution Status:
In Commercial Distribution
DUNS Number:
679894738
Device Count:
3870
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Device ID:
06931918186187
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16931918186184
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 65175
Name: Operating room turnover kit
Definition:
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.
FDA Product Codes
KME
Bedding, Disposable, Medical