SAM Pelvic Sling II

Basic Information

• Brand Name: SAM Pelvic Sling II
• Primary DI: 00822045428645
• Version / Model: PS302-OB-EN
• Company Name: SAM Medical Products
• Labeler DUNS: 131084188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-01
• Public Version: 2
• Public Version Date: 2023-01-20
• Public Version Status: Update
• Public Device Record Key: d1cde6ba-8ef3-4c67-9d0e-4cdde927565f

Device Description

SAM PELVIC SLING LARGE

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IPW	Orthosis, Sacroiliac, Soft	Physical Medicine	890.3490	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63496	Pelvic fracture binder, single-use	A belt-like support designed to be wrapped tightly around the pelvis (around the greater trochanters) of a patient suspected of a pelvic fracture to support the pelvis during transportation. Sometimes referred to as a pelvic belt or sling, it is typically intended to be used in an emergency setting. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10822045428642	GS1	Case	24	In Commercial Distribution
Primary	00822045428645	GS1

Customer Contacts

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