I-pak

Basic Information

• Brand Name: I-pak
• Primary DI: 00814639020694
• Version / Model: D002-009-P
• Catalog Number: D002-009-P
• Company Name: APPLIED DENTAL, INC.
• Labeler DUNS: 017524666
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-03-10
• Public Version: 2
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: d99b59ee-fed6-47e6-91d1-1f116156bc33

Device Description

Sterile Dental I-pak (Intraoral Exam pack) with mirror, probe & explorer. Disposable.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
EAX	Mirror, Mouth	Dental	872.4565	1
EIX	Probe, Periodontic	Dental	872.4565	1
EKB	Explorer, Operative	Dental	872.4565	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31848	Periodontal probe, reusable	A hand-held dental instrument intended to be inserted into a periodontal pocket around a tooth to measure the depth of the periodontal pocket, in order to assess the health of the periodontium and to monitor the progress of disease. It is typically made of high-grade stainless steel and has a distal end with a thin, angled or curved blunt tip with scaled markings to indicate measurements (typically millimetres). This is a reusable device.	No	Obsolete
31776	Dental mirror, reusable	A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.	No	Active
35812	Dental surgical probe, reusable	A slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30814639020695	GS1	box	50	In Commercial Distribution
Primary	00814639020694	GS1
Package	50814639020699	GS1	Carton	16	In Commercial Distribution

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 40 Degrees Celsius