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Thunderbolt

FDA UDI

Class I (US FDA UDI)

by Responsive Orthopedics Llc

Identity

Trade Name
Thunderbolt FDA UDI
Generic Name
Suture/ligature tightener, reusable FDA UDI
Device Name
Thunderbolt Tensioner Middle FDA UDI
Model / Reference
285970 FDA UDI
Description
Thunderbolt Tensioner Middle FDA UDI

Identifiers

Catalog Number
285970 FDA UDI
Primary DI / UDI-DI
00811714036588 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Suture/ligature tightener, 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: Suture/ligature tightener, reusable

Thunderbolt by Responsive Orthopedics Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suture/ligature tightener, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Responsive Orthopedics Llc

Sources (1)

  • FDA UDI 9b15cf9c-4256-4cc6-98e5-2ab817f420ba 34 fields · synced May 31, 2026