RTMED

Basic Information

• Brand Name: RTMED
• Primary DI: 06971642800034
• Version / Model: 7.5cm×30cm
• Company Name: Shandong Haidike Medical Products Co., Ltd.
• Labeler DUNS: 550402542
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 488cf1b2-0b33-4a7c-97a0-19484208cd21

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: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• 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
43565	Arm splint system, self-moulding	A collection of non-sterile devices designed to produce a moulded splint that is formed around the upper limb of a patient who requires support or immobilization (e.g., to treat fractures, injuries, strains, sprains). It typically consists of a two-component polyurethane that is mixed and poured into a textile which matches this part of the body creating a rigid or soft foam splint that is applied to the patient’s arm where it sets. It is available in different sizes. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06971642800034	GS1