Smoltap

Basic Information

• Brand Name: Smoltap
• Primary DI: 00860008770615
• Version / Model: STSTR1
• Catalog Number: STSTR1
• 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: 49efd70a-2aef-4816-bc7c-15dd251439d5

Device Description

Infant Stabilizer Straps

Device Characteristics

• Single Use: Yes
• 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: 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
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
Package	10860008770612	GS1	Box	10	In Commercial Distribution
Primary	00860008770615	GS1

Customer Contacts

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