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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
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
PELVIC EXAM TRAY FDA UDI
Model / Reference
14-117-1 FDA UDI
Description
PELVIC EXAM TRAY FDA UDI

Identifiers

Primary DI / UDI-DI
10840200301425 FDA UDI
510(k) Number
K812133 FDA UDI
FDA Product Code
FSM FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, 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

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Category: General surgical procedure kit, non-medicated, single-use

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

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

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 fea179be-151a-468a-b9dc-cd57f7cc2cd1 36 fields · synced May 30, 2026