Smoltap

Basic Information

• Brand Name: Smoltap
• Primary DI: 00860008770608
• Version / Model: STCR1
• Catalog Number: STCR1
• Company Name: Smoltap, Inc.
• Labeler DUNS: 130517966
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-27
• Public Version: 1
• Public Version Date: 2022-11-04
• Public Version Status: New
• Public Device Record Key: 233092ae-9f83-4406-b721-56dbfa25549a

Device Description

Infant Stabilizer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• 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
PRN	Pediatric Position Holder	General Hospital	880.5680	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12097	Infant limb immobilizer, reusable	A non-rigid device, usually made of a fabric and/or plastic materials, used to temporarily render parts of an infant's body immovable, e.g., the arms and/or feet while the patient undergoes therapeutic or diagnostic interventions. It will typically be used to prevent the patient from interrupting an intravenous (IV) infusion, pulling out a catheter, or interfering with wound care. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008770608	GS1

Customer Contacts

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