Otopore

Basic Information

• Brand Name: Otopore
• Primary DI: 07613327301656
• Version / Model: 5400020100
• Catalog Number: 5400-020-100
• Company Name: STRYKER CORPORATION
• Labeler DUNS: 196548481
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2022-03-23
• Public Version Status: Update
• Public Device Record Key: 174055ef-fb44-44bc-970a-c1c5a7c47d4c

Device Description

Square Firm

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• 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
NHB	POLYMER, EAR, NOSE AND THROAT, SYNTHETIC, ABSORBABLE	Ear, Nose, Throat	874.3620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35288	Ear wick, biodegradable	A fragmentable packing, composed of a biodegradable material [e.g., poly(DL-lactide-co-caprolactone)], intended to prevent adhesions between mucosal surfaces in the ear of a patient undergoing outer ear surgery. It typically helps to mimimize bleeding via a tamponade effect and blood absorption. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613327301657	GS1	pack	8	In Commercial Distribution
Primary	07613327301656	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	4.0	Centimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: High: 4 Degrees Celsius