E.M Adams co, inc.

FDA UDI

Class I (US FDA UDI)

by E.M. Adams

Identity

Trade Name: E.M Adams co, inc. FDA UDI
Generic Name: Suturing unit, single-use FDA UDI
Device Name: SINGLE INSTRUMENT FDA UDI
Model / Reference: 14-3346-1 FDA UDI
Description: SINGLE INSTRUMENT FDA UDI

Identifiers

Primary DI / UDI-DI: 10840200301906 FDA UDI
510(k) Number: K812133 FDA UDI
FDA Product Code: FSM FDA UDI
GMDN Term: Suturing unit, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

Category: Suturing unit, single-use

E.M Adams co, inc. by E.M. Adams — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Suturing unit, single-use.

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Cleared under the same submission

K812133 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: E.M. Adams

Sources (1)

FDA UDI ba42e3d5-a817-4fce-9cc7-95fbe9d77a83 36 fields · synced Jun 8, 2026