E.M Adams co, inc.

Basic Information

• Brand Name: E.M Adams co, inc.
• Primary DI: 10840200302309
• Version / Model: 14-3444-1
• Company Name: E.M. ADAMS, INC.
• Labeler DUNS: 001403807
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-21
• Public Version: 1
• Public Version Date: 2021-05-31
• Public Version Status: New
• Public Device Record Key: 33069649-f9f9-437b-8509-c2721dfaa70c

Device Description

PAPER TAPE MEASURE

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
63434	Tape measure, single-use	A flexible device intended to be used in a clinical setting to establish an accurate measurement of length greater than a standard ruler (e.g., general anatomical measurements of newborn babies). It is typically made of silk-coated paper and marked in units of length (i.e., inches and/or millimetres); some types may have a writing field to record patient data (e.g., name, sex, date of birth). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50840200302291	GS1	Case	100	In Commercial Distribution
Primary	10840200302309	GS1
Package	30840200302310	GS1	BX	20	In Commercial Distribution

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/PAPER TAPE MEASURE