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Denali

FDA UDI

Class I (US FDA UDI)

by Orthodontic Supply & Equipment Co., Inc.

Identity

Trade Name
DENALI FDA UDI
Generic Name
Dressing/utility forceps, tweezers-like, reusable FDA UDI
Device Name
Keat Buccal Tube Tweezer FDA UDI
Model / Reference
0112-060 FDA UDI
Description
Keat Buccal Tube Tweezer FDA UDI

Identifiers

Primary DI / UDI-DI
00810042120259 FDA UDI
FDA Product Code
KCX FDA UDI
GMDN Term
Dressing/utility forceps, tweezers-like, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.5360 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dressing/utility forceps, tweezers-like, reusable

Denali by Orthodontic Supply & Equipment Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dressing/utility forceps, tweezers-like, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthodontic Supply & Equipment Co., Inc.

Sources (1)

  • FDA UDI ddfe92d5-7eef-49f5-aff4-fb58218f94d8 33 fields · synced Jun 1, 2026