E.M Adams co, inc.

Basic Information

• Brand Name: E.M Adams co, inc.
• Primary DI: 58100013404783
• Version / Model: 3030
• Company Name: E.M. ADAMS, INC.
• Labeler DUNS: 001403807
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-31
• Public Version: 2
• Public Version Date: 2021-06-22
• Public Version Status: Update
• Public Device Record Key: e4d448d8-7f5d-45bd-9112-38d96639a2c0
• Distribution End Date: 2021-06-21

Device Description

UNIVERSAL KNEE SPLINT

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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
HSP	Splint, Traction	Orthopedic	888.5890	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37470	Padded stays splint, reusable	A non-sterile padded device designed to immobilize and protect an injured body extremity (arm or leg) during the healing process. It is in the form of a preshaped rigid mould (with padding) intended to be held in place with straps/bandages (not included); it is not primarily intended for use in an emergency setting and is not intended for chronic/long-term use after healing. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	58100013404783	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			27" X22" X20" BODY/2" X 22" STRAP