E.M Adams co, inc.

Basic Information

• Brand Name: E.M Adams co, inc.
• Primary DI: 18100013402040
• Version / Model: 14-3358-1
• Company Name: E.M. ADAMS, INC.
• Labeler DUNS: 001403807
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-31
• Public Version: 4
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: a2fea0ec-527e-4827-ac2f-8a6004542beb
• Distribution End Date: 2021-02-28

Device Description

SINGLE INSTRUMENT

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62490	Dressing/utility forceps, scissors-like, single-use	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is not intended for endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	58100013402031	GS1	Case	100	Not in Commercial Distribution	2021-02-28
Primary	18100013402040	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K812133	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			5" X 9" POUCH/FOERSTER SPONGE FORCEPS