Cramer De-Hesive

Basic Information

• Brand Name: Cramer De-Hesive
• Primary DI: 00311960436281
• Version / Model: 040432
• 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: e2b8d22c-b689-47d0-8047-b50e2e765951

Device Description

Cramer De-Hesive, 1 8oz. Non-aerosol pump spray bottle, 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
Primary	00311960436281	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	8	Fluid Ounce

Storage Conditions

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