Hintermann Series H2

Basic Information

• Brand Name: Hintermann Series H2
• Primary DI: B095322327
• Version / Model: 1
• Catalog Number: 322327
• Company Name: Dt Medtech, LLC
• Labeler DUNS: 080101891
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-03-20
• Public Version: 4
• Public Version Date: 2020-10-16
• Public Version Status: Update
• Public Device Record Key: c535915d-afb8-4099-a622-ca5c4744c346

Device Description

H2 PE INLAY SIZE 3 LEFT 7MM/POSTERIOR

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	888.3110	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48180	Ankle prosthesis bearing	A sterile implantable device made of polyethylene (PE) designed to articulate the tibial and talar components of a total ankle prosthesis.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B095322327	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K171004	000