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Sequel Medical

FDA UDI

Class II (US FDA UDI)

by Sequel Medical, Inc.

Identity

Trade Name
Sequel Medical FDA UDI
Generic Name
External orthopaedic fixation system, single-use FDA UDI
Device Name
Hinges Male Standard FDA UDI
Model / Reference
IM11800003 FDA UDI
Description
Hinges Male Standard FDA UDI

Identifiers

Catalog Number
IM11800003 FDA UDI
Primary DI / UDI-DI
00810071320194 FDA UDI
FDA Product Code
KTT FDA UDI
JDW FDA UDI
GMDN Term
External orthopaedic fixation system, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
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
MRI Safety
MR Unsafe FDA UDI

Category: External orthopaedic fixation system, single-use

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

Similar devices

Also classified as External orthopaedic fixation system, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Sequel Medical, Inc.

Sources (1)

  • FDA UDI 581e69c6-e645-4951-a4ef-9461666ca96f 35 fields · synced Jun 8, 2026