Model: MUR-000013
Catalog: MUR-000013
DI: 10810068811077
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Equipment drapes
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
95c4b409-851d-48bf-ab6f-d78f6bf7006b
Distribution Status:
In Commercial Distribution
DUNS Number:
015823456
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
Yes
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:
No
Identifiers
Item #1 - Device ID:
10810068811077
Item #1 - Device ID Type:
Primary
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Pkg Type:
Shelf Box
Item #2 - Device ID:
20810068811074
Item #2 - Pkg Status:
In Commercial Distribution
Item #2 - Pkg Quantity:
1
Item #2 - Device ID Type:
Package
Item #2 - Contains DINumber:
10810068811077
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Shipper Box
Item #3 - Device ID:
30810068811071
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
1
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
20810068811074
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 12535
Name: Medical equipment/instrument drape, single-use
Definition:
A flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity of, a hygienic area; it may have patient contact, however it is not intended to be introduced into a body cavity (noninvasive). It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.
FDA Product Codes
PUI
Drape, Surgical, Exempt
Premarket Submissions
Submission Number:
K213334
Supplement Number:
000