Model: 300
Catalog: 300
DI: 07466532979338
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
Maestro TM Two-Arm Drape (300)
Sterilization
Method Types - Sterilization Method:
Ethylene Oxide
Device Sterile:
Yes
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
4c0601b3-f4a5-44c1-b96f-ad3bcbe5a930
Distribution Status:
In Commercial Distribution
DUNS Number:
817435655
Device Count:
1
DM Exempt:
Yes
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
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:
27466532979332
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
07466532979338
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
07466532979338
Item #2 - Device ID Type:
Primary
Item #2 - 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