Cramer Tape Remover

Basic Information

• Brand Name: Cramer Tape Remover
• Primary DI: 00311960439091
• Version / Model: 201033
• Company Name: CRAMER PRODUCTS, INC.
• Labeler DUNS: 007138183
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-01
• Public Version: 2
• Public Version Date: 2019-03-11
• Public Version Status: Update
• Public Device Record Key: 09ab5552-049d-4d6d-80d8-523909fa1aae

Device Description

Cramer Tape Remover, 1 16 oz. bottle of tape remover, Solvent, Adhesive Tape

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• 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
KOX	Solvent, Adhesive Tape	General, Plastic Surgery	878.4730	1

GMDN Terms

Code	Name	Definition	Implantable	Status
60494	Patient medical adhesive remover	A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10311960439098	GS1	Master Carton	12	In Commercial Distribution
Primary	00311960439091	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	16	Fluid Ounce

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Do not store near heat or flame. Do not store at temperature above 120 F. Keep out of reach of children.