← Back to catalogue

Dolphix

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name
DOLPHIX FDA UDI
Generic Name
Orthopaedic implant aiming/guiding block, reusable FDA UDI
Model / Reference
Bone screw extension FDA UDI

Identifiers

Catalog Number
DF900030 FDA UDI
Primary DI / UDI-DI
08032909627639 FDA UDI
510(k) Number
K163323 FDA UDI
FDA Product Code
JDW FDA UDI
KTT FDA UDI
GMDN Term
Orthopaedic implant aiming/guiding block, reusable FDA UDI

Classification

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

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 Conditional FDA UDI

Category: Orthopaedic implant aiming/guiding block, reusable

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

Similar devices

Also classified as Orthopaedic implant aiming/guiding block, reusable.

Cleared under the same submission

K163323 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Citieffe

Sources (1)

  • FDA UDI 8dea5ddf-143f-45a6-b822-b8c612165697 36 fields · synced Jun 1, 2026