← Back to catalogue

Scarlet Ac-T Instrumentation

FDA UDI

Class II (US FDA UDI)

by Spineart

Identity

Trade Name
SCARLET AC-T INSTRUMENTATION FDA UDI
Generic Name
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Device Name
Pins Ø 4.2 L18 FDA UDI
Model / Reference
SCA-IN 40 18-S FDA UDI
Description
Pins Ø 4.2 L18 FDA UDI

Identifiers

Catalog Number
SCA-IN 40 18-S FDA UDI
Primary DI / UDI-DI
07640151089115 FDA UDI
FDA Product Code
OVE FDA UDI
GMDN Term
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 FDA UDI
Commercial Distribution
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

Yes

FDA UDI

Category: Intraoperative orthopaedic bone pin/screw, single-use

Scarlet Ac-T Instrumentation by Spineart — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative orthopaedic bone pin/screw, single-use.

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
Spineart

Sources (1)

  • FDA UDI b37644f8-c88f-4819-a35f-b4a56ec45834 34 fields · synced May 30, 2026