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Charlotte

FDA UDI

Class II (US FDA UDI)

by Wright Medical Technology, Inc.

Identity

Trade Name
CHARLOTTE FDA UDI
Generic Name
Implantable bone washer FDA UDI
Model / Reference
44187000 FDA UDI

Identifiers

Catalog Number
44187000 FDA UDI
Primary DI / UDI-DI
00840420109316 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Implantable bone washer FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Implantable bone washer

Charlotte by Wright Medical Technology, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable bone washer.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 4de56ef9-5294-4dc5-9e78-546994351217 35 fields · synced Jun 8, 2026