Dale Transducer Holder, 3-Tab

Basic Information

• Brand Name: Dale Transducer Holder, 3-Tab
• Primary DI: 00817612020841
• Version / Model: 620
• Catalog Number: 620
• Company Name: DALE MEDICAL PRODUCTS, INC.
• Labeler DUNS: 001061233
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-24
• Public Version: 1
• Public Version Date: 2019-07-02
• Public Version Status: New
• Public Device Record Key: b1cbe95b-6fd1-41f9-ac62-aa435ab3c708

Device Description

Dale Transducer Holder, Fits most

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGX	Tape And Bandage, Adhesive	General Hospital	880.5240	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37318	Electrode/transducer strap, single-use	A strip of material (e.g., fabric) intended to be used to hold electrodes and/or transducers (e.g., foetal monitoring transducers) in place on the body surface; it typically has fasteners (e.g., Velcro, buckle). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Previous	H84106201	HIBCC
Package	00817612020858	GS1	Box	10	In Commercial Distribution
Primary	00817612020841	GS1