Bioseal Inc.

Basic Information

• Brand Name: Bioseal Inc.
• Primary DI: 00630094171333
• Version / Model: 17133/20
• Company Name: BIOSEAL
• Labeler DUNS: 186968939
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-18
• Public Version: 1
• Public Version Date: 2023-09-26
• Public Version Status: New
• Public Device Record Key: 61ea9624-2356-4823-b20c-c6d67b2cb14d

Device Description

Stirrup Strap

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: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMP	Protector, skin pressure	General Hospital	880.6450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44851	Limb/torso/head restraint, single-use	A non-rigid device, typically a strap(s), band(s) or garment-like, intended to be temporarily placed on or around one or more parts of a patient’s body (e.g., torso, limbs, head) to restrict movement, to facilitate patient positioning and stabilization during a medical procedure, and/or to prevent injury/hazards while potentially permitting limited movement. It is made of various materials (e.g., fabric, nylon, leather, or foam) and typically anchored to a fixture or furniture part (e.g., a bedrail, operating table). It is not intended for immobilization of specific joint. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10630094171330	GS1	Case	20	In Commercial Distribution
Primary	00630094171333	GS1