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Dolphix

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name
DOLPHIX FDA UDI
Generic Name
External orthopaedic fixation system, single-use, sterile FDA UDI
Device Name
Surgical guide for pre-drill wire insertion with soft tissue protection. Material: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI
Model / Reference
Soft tissue protection guide FDA UDI
Description
Surgical guide for pre-drill wire insertion with soft tissue protection. Material: titanium alloy Ti6Al4V ELI (ASTM F136). FDA UDI

Identifiers

Catalog Number
DF900025 FDA UDI
Primary DI / UDI-DI
08032909629572 FDA UDI
510(k) Number
K132363 FDA UDI
FDA Product Code
JDW FDA UDI
KTT FDA UDI
GMDN Term
External orthopaedic fixation system, single-use, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 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

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dolphix by Citieffe — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K132363 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Citieffe

Sources (1)

  • FDA UDI 269f0d15-131a-4863-ad23-ca673b7d8cda 38 fields · synced Jun 1, 2026