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SurePass CTR

FDA UDI

Class I (US FDA UDI)

by Dev4

Identity

Trade Name
SurePass CTR FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Carpal Tunnel Release, (1) SurePass CTR Guide, (1) SurePass CTR Knife Blade FDA UDI
Model / Reference
CT-1000 FDA UDI
Description
Carpal Tunnel Release, (1) SurePass CTR Guide, (1) SurePass CTR Knife Blade FDA UDI

Identifiers

Primary DI / UDI-DI
00860011634812 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, single-use 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

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

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, single-use

SurePass CTR by Dev4 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dev4

Sources (1)

  • FDA UDI 3e077c58-dd93-4fde-aef1-8f473f6bdff5 34 fields · synced Jun 8, 2026