Supprelin LA

Basic Information

• Brand Name: Supprelin LA
• Primary DI: 00367979002009
• Version / Model: 6797900200
• Company Name: ENDO PHARMACEUTICALS INC.
• Labeler DUNS: 178074951
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-06-05
• Public Version: 2
• Public Version Date: 2019-07-12
• Public Version Status: Update
• Public Device Record Key: 03444352-2563-48b5-adde-c60cf44646ec

Device Description

Supprelin Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63200	Subcutaneous implantation kit, medicated	A collection of various surgical instruments and materials, including a pharmaceutical component (e.g., local anaesthetic), intended for subcutaneous delivery of an implantable drug pellet/implant (not included). It typically includes a dedicated implantation tool/cannula with non-dedicated supportive devices (e.g., dressings, drapes, clamps). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00367979002009	GS1

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 20 – 25 Degrees Celsius