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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
18100013401906 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

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

Cleared under the same submission

K812133 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
E.M. Adams

Sources (1)

  • FDA UDI 5e4a7415-f5ac-48b6-bab1-378584e7faf9 37 fields · synced May 31, 2026