WALTER AUFRICHT NASAL RETRACTOR

Basic Information

• Brand Name: WALTER AUFRICHT NASAL RETRACTOR
• Primary DI: 00192896098725
• Version / Model: 207-2928T
• Catalog Number: 207-2928T
• Company Name: SONTEC INSTRUMENTS, INC.
• Labeler DUNS: 040729840
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-26
• Public Version: 1
• Public Version Date: 2019-09-03
• Public Version Status: New
• Public Device Record Key: 48780cc0-9875-46fe-a325-4526218f7a6c

Device Description

WALTER AUFRICHT NASAL RETRACTOR DOUBLE ENDED BLUNT BLADE

Device Characteristics

• Single Use: No
• 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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: ["Moist Heat or Steam Sterilization", "Dry Heat Sterilization"]

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KAL	Retractor, Ent	Ear, Nose, Throat	874.4420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45918	Hand-held surgical retractor, reusable	A hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00192896098725	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	5.25	Inch
Device Size Text, specify			8 Millimeter Tip