Model: 9358
Catalog: 9358
DI: 10192253069662
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Half Sheet
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
91e89f9f-7932-4c79-9b84-e53d3de49447
Distribution Status:
In Commercial Distribution
DUNS Number:
961027315
Device Count:
1
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:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
CASE
Item #1 - Device ID:
50192253069660
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
20
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10192253069662
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10192253069662
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