Device
Half body incise drape_SMS_1 bag_164x140cm_Non-sterile_34ea/cs
Manufacturer
GRI Medical & Electronic Technology Co., Ltd.
GRI Medical & Electronic Technology Co., Ltd.
Model: 60300688
DI: 16931918155036
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
Half body incise drape_SMS_1 bag_164x140cm_Non-sterile_34ea/cs
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b3068864-8f41-45f4-b88f-73f5c4254029
Distribution Status:
In Commercial Distribution
DUNS Number:
679894738
Device Count:
34
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:
06931918155039
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
16931918155036
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 47783
Name: Patient surgical drape, single-use
Definition:
A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.
FDA Product Codes
PUI
Drape, Surgical, Exempt