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Scarlet® Al-T

FDA UDI

Class I (US FDA UDI)

by Spineart

Identity

Trade Name
SCARLET® AL-T FDA UDI
Generic Name
Surgical drill guide, reusable FDA UDI
Device Name
DAS GUIDE L 10-12 FDA UDI
Model / Reference
SPE-US 00 77-N FDA UDI
Description
DAS GUIDE L 10-12 FDA UDI

Identifiers

Catalog Number
SPE-US 00 77-N FDA UDI
Primary DI / UDI-DI
07640450863195 FDA UDI
FDA Product Code
HWR FDA UDI
GMDN Term
Surgical drill guide, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

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

The SCARLET AL-T medical device is a surgical drill guide designed for orthopedic procedures. It features a tubular or guiding hole design, serrations at the distal end to enable firm placement on hard tissue surfaces, and can be held by another device, providing protection of surrounding soft tissue during surgery. This reusable device is suitable for implantable applications.

Similar devices

Also classified as Surgical drill guide, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineart

Sources (1)

  • FDA UDI 510ae4ad-3af9-4378-b029-60d2fdf30ac4 34 fields · synced Jun 28, 2026