← Back to catalogue

Estremo

FDA UDI

Class II (US FDA UDI)

by Citieffe

Identity

Trade Name
ESTREMO FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
Tissue protection sleeve with AO quick connection FDA UDI
Model / Reference
Tissue protection sleeve AO joint, suprapatellar FDA UDI
Description
Tissue protection sleeve with AO quick connection FDA UDI

Identifiers

Catalog Number
DT030023 FDA UDI
Primary DI / UDI-DI
08059386741948 FDA UDI
510(k) Number
K181540 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Surgical drill guide, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 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

Category: Surgical drill guide, reusable

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

Similar devices

Also classified as Surgical drill guide, reusable.

Cleared under the same submission

K181540 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 fb2858e4-1700-4104-8139-ee34c4b4b491 37 fields · synced Jun 8, 2026