Passing Needle Kit with Obturator

Basic Information

• Brand Name: Passing Needle Kit with Obturator
• Primary DI: 00841823100436
• Version / Model: APNK1-5.0X
• Catalog Number: APNK1-5.0X
• Company Name: Ad-Tech Medical Instrument Corporation
• Labeler DUNS: 174813410
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-09
• Public Version: 2
• Public Version Date: 2023-08-23
• Public Version Status: Update
• Public Device Record Key: a76a8523-9223-44a1-af16-0b5610e29e73

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: 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
HWQ	PASSER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32864	Wire/ligature passer, reusable	A hand-held, manual surgical instrument designed for passing a length of a flexible material/device, typically a wire, ligature, or orthopaedic graft gauge, through a surgical site by creating a pathway through tissue and facilitating the introduction and handling of the material/device. It may also be referred to as a carrier and is typically in the form of a shaft with a distal clasp, grasping arm, or cannulated hook to hold the material being passed through the tissue. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	90841823100439	GS1		5	In Commercial Distribution
Primary	00841823100436	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: To be stored and used within typical hospital/office room ambient temperature and humidity conditions