E.M Adams co, inc.

Basic Information

• Brand Name: E.M Adams co, inc.
• Primary DI: 10840200300688
• Version / Model: 114-31333-1
• Company Name: E.M. ADAMS, INC.
• Labeler DUNS: 001403807
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-20
• Public Version: 1
• Public Version Date: 2021-05-28
• Public Version Status: New
• Public Device Record Key: 56c35144-885b-4c76-9a4e-2e95c23dbf19

Device Description

CIRCUMCISION TRAY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: Yes
• 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: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OHG	Circumcision Tray	Obstetrics/Gynecology	884.4530	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34945	Circumcision kit, single-use	A collection of sterile devices designed to perform a circumcision procedure. It typically includes a disinfectant, circumcision clamp, scissors, and a scalpel. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50840200300679	GS1	case	20	In Commercial Distribution
Primary	10840200300688	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			8.75" X 7" X 1.25"