Explorer Swim Module SML without spacer

Basic Information

• Brand Name: Explorer Swim Module SML without spacer
• Primary DI: 04262429650075
• Version / Model: 0104(3/4)000
• Company Name: macu4 GmbH
• Labeler DUNS: 344157954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-11-23
• Public Version: 1
• Public Version Date: 2025-12-01
• Public Version Status: New
• Public Device Record Key: eeff1f44-dacf-4ce6-8420-df1890e7fc57

Device Characteristics

• Single Use: No
• 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: MR Unsafe
• 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISZ	Unit, Wrist, External Limb Component, Mechanical	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41078	Passive hand prosthesis	An artificial substitute for a missing hand that may be attached to a natural arm or used as part of an upper-limb external prosthetic system, and is designed to move only as a result of the direct application of external forces.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04262429650075	GS1