GLASSCOCK NEUROTOLOGY SURGERY DRAPE

Basic Information

• Brand Name: GLASSCOCK NEUROTOLOGY SURGERY DRAPE
• Primary DI: 00850000126091
• Version / Model: SD-2200
• Company Name: Oto-Med, Inc.
• Labeler DUNS: 059817742
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 5
• Public Version Date: 2021-12-22
• Public Version Status: Update
• Public Device Record Key: b2dbca16-29f8-493d-8f28-a1411e7cf86d

Device Description

GLASSCOCK NEUROTOLOGY SURGERY DRAPE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PUI	Drape, Surgical, Exempt	General, Plastic Surgery	878.4370	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47783	Patient surgical drape, single-use	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850000126091	GS1
Package	10850000126098	GS1		6	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]