CUSTOMED

Basic Information

• Brand Name: CUSTOMED
• Primary DI: M2089000120
• Version / Model: 712057200012
• Catalog Number: 900012
• Company Name: CUSTOMED INC
• Labeler DUNS: 627572217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 08ea62cb-13c9-4349-8c71-04216eb04b2c

Device Description

OB SURGICAL PACK HOSPITAL SAN CRISTOBAL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
HHD	Pad, Menstrual, Unscented	Obstetrics/Gynecology	884.5435	1

GMDN Terms

Code	Name	Definition	Implantable	Status
44060	Obstetrical/gynaecological surgical procedure kit, medicated	A collection of various sterile surgical instruments, dressings, pharmaceuticals, and materials intended to be used during obstetrical/gynaecological surgery; it is a general-purpose obstetrical/gynaecological surgical kit, and as such is not dedicated to a specific procedure. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M2089000122	HIBCC	4/CS	4	In Commercial Distribution
Primary	M2089000120	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K902271	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in Cool Dry Place