Hemorrhage Occluder Pin with Applicator

Basic Information

• Brand Name: Hemorrhage Occluder Pin with Applicator
• Primary DI: 00868742000104
• Version / Model: CR1007
• Catalog Number: CR1007
• Company Name: SURGIN SURGICAL INSTRUMENTATION, INC.
• Labeler DUNS: 076656164
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-20
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 03b709cf-b3b0-4d9b-8454-bbfef1dce6d7

Device Description

Hemorrhage Occluder Pin Standard - 10 mm head

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: Yes
• 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
GDW	Staple, Implantable	General, Plastic Surgery	878.4750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46121	Haemorrhage control pin	A thumbtack-like implant typically intended to be used during pelvic surgery to control severe, localized bleeding from veins in the presacral area. It is implanted through a presacral vein into the sacrum (fused vertebral bones of the lower spine) after other methods of haemostasis (e.g., cauterization, suturing, clamping) have been determined ineffective. The device is made of metal [e.g., titanium (Ti)], having a large disk-like head and a serrated shaft. It may be attached to a disposable pin applicator that helps the surgeon position it prior to pressing it into place.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00868742000104	GS1
Package	10868742000101	GS1	Box	2	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K890447	000

Device Sizes

Type	Value	Unit	Text
Width	10	Millimeter