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TransFasten

FDA UDI

Class I (US FDA UDI)

by Captiva Spine

Identity

Trade Name
TransFasten FDA UDI
Generic Name
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Device Name
Marking Pin, 229mm, Non-Threaded Trocar, Blunt, SS FDA UDI
Model / Reference
98514-6229 FDA UDI
Description
Marking Pin, 229mm, Non-Threaded Trocar, Blunt, SS FDA UDI

Identifiers

Primary DI / UDI-DI
M7399851462290 FDA UDI
FDA Product Code
LXH FDA UDI
KIL FDA UDI
FZX FDA UDI
GMDN Term
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
878.4800 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 229 Millimeter FDA UDI

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

TransFasten by Captiva Spine — Class I — 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

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Manufacturer

Manufacturer
Captiva Spine

Sources (1)

  • FDA UDI c67f1370-928b-4db4-88cc-8092d983b8ab 35 fields · synced May 30, 2026