Thunderbolt

Primary DI
00811714036618
Brand
Thunderbolt
Company
RESPONSIVE ORTHOPEDICS LLC
Model
285973
Catalog number
285973
Device description
Thunderbolt Drill Guide Insert
Published
2025-05-14
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811714036618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811714036618008117140366188117140366180811714036618

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002745858
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811714036472Thunderbolt2859592859592026-07-31
00811714036489Thunderbolt2859602859602026-07-31
00811714036533Thunderbolt2859652859652025-05-14
00811714036540Thunderbolt2859662859662025-05-14
00811714036557Thunderbolt2859672859672025-05-14
00811714036564Thunderbolt2859682859682025-05-14
00811714036571Thunderbolt2859692859692025-05-14
00811714036588Thunderbolt2859702859702025-05-14
00811714036595Thunderbolt2859712859712025-05-14
00811714036601Thunderbolt2859722859722025-05-14
00811714036403Shadow Mini Instruments2859522859522026-02-03
00811714036427Shadow Knotless Instruments2859542859542026-02-03
00811714036397Shadow Mini All-Suture Anchor2859512859512025-05-14
00811714036380Shadow Instruments2859502859502025-12-31
00811714036373Shadow All-Suture Anchor2859492859492025-05-14
00811714036625Mini Superhawk Suture Anchor2859802859802025-12-09
00811714036632Mini Superhawk2859752859752025-12-09
00811714036663Mini Superhawk2859782859782025-12-09
00811714036670Mini Superhawk2859792859792025-12-09
00811714036731Osprey Suture Anchor2859852025-12-09

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Primary DI, Brand, Company table
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00888867550315Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550322Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550339Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550346Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550353Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550360Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550377Arthrex®ARTHREX, INC.LXH2026-09-18
00888867550384Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552692Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552708Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552715Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552722Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552739Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552746Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552753Arthrex®ARTHREX, INC.LXH2026-09-18
00888867552760Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574564Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574571Arthrex®ARTHREX, INC.LXH2026-09-18
00888867574588Arthrex®ARTHREX, INC.LXH2026-09-18
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04054896000923AdapterSilony Medical GmbHLXH2026-09-18