BMI

Basic Information

• Brand Name: BMI
• Primary DI: G088HSGLR0
• Version / Model: HSG-LR
• Catalog Number: HSG-LR
• Company Name: Blake Manufacturing, Inc.
• Labeler DUNS: 103449711
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-15
• Public Version: 1
• Public Version Date: 2022-08-23
• Public Version Status: New
• Public Device Record Key: d9f09ea7-d5ed-43e8-9dd6-72351661969b

Device Description

Slim Grip Hand orthosis, size: Large, side: Right

Device Characteristics

• Single Use: No
• 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: 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILH	Splint, Hand, And Components	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41459	Wrist/hand orthosis	An externally applied orthopaedic appliance or apparatus designed to support, correct, or improve function of the wrist and hand through actions such as alignment, hinge-support, or dorsiflexion assistance. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G088HSGLR0	HIBCC