Bone Spreader 027-401

GUDID 00688346001488

Laboratoires Bodycad Inc

Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal Orthopaedic surgical distractor, internal
Primary Device ID00688346001488
NIH Device Record Keybb5008ac-53e1-4f23-b64a-d48847d0c126
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Spreader
Version Model Number027-401
Catalog Number027-401
Company DUNS202981171
Company NameLaboratoires Bodycad Inc
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100688346001488 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

[00688346001488]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-23
Device Publish Date2023-02-15

Devices Manufactured by Laboratoires Bodycad Inc

00688346000047 - Fine Osteotomy system - Proximal tibia2024-02-19 Proximal tibia, plate, screws (compression cortical/cancellous), guides
00688346000078 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, screws (compression cortical/cancellous), guides
00688346000108 - Fine Osteotomy implants - Distal femur2024-02-19 Distal femur, plate, screws (cortical/cancellous compression)
00688346000122 - Fine Osteotomy implants - Proximal tibia2024-02-19 Proximal tibia, plate, screws (cortical/cancellous compression)
00688346000283 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, screws (cortical locking, cancellous compression), guides
00688346000290 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, cancellous screws compression, guides
00688346000320 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, cortical locking screws, guides
00688346000337 - Fine Osteotomy system - Distal femur2024-02-19 Distal femur, plate, screws (cortical locking, cortical compression), guides
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