FDA.reportPublic FDA data

Explorer

Primary DI
00688346001440
Brand
Explorer
Company
Laboratoires Bodycad Inc
Model
020-139
Catalog number
020-139
Published
2023-02-10
Public version status
New
Distribution status
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
00688346001440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00688346001440006883460014406883460014400688346001440

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
202981171
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
false
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
00688346000047Fine Osteotomy system - Proximal tibia015-410-001015-410-0012020-05-20
00688346000078Fine Osteotomy system - Distal femur015-330-001015-330-0012020-05-20
00688346000108Fine Osteotomy implants - Distal femur015-330-101015-330-1012020-05-20
00688346000122Fine Osteotomy implants - Proximal tibia015-410-101015-410-1012020-05-20
00688346000283Fine Osteotomy system - Distal femur015-330-002015-330-0022020-05-20
00688346000290Fine Osteotomy system - Distal femur015-330-003015-330-0032020-05-20
00688346000320Fine Osteotomy system - Distal femur015-330-006015-330-0062020-05-20
00688346000337Fine Osteotomy system - Distal femur015-330-007015-330-0072020-05-20
00688346000344Fine Osteotomy implants - Distal femur015-330-102015-330-1022020-05-20
00688346000351Fine Osteotomy implants - Distal femur015-330-103015-330-1032020-05-20
00688346000368Fine Osteotomy implants - Distal femur015-330-104015-330-1042020-05-20
00688346000375Fine Osteotomy implants - Distal femur015-330-105015-330-1052020-05-20
00688346000382Fine Osteotomy implants - Distal femur015-330-106015-330-1062020-05-20
00688346000399Fine Osteotomy implants - Distal femur015-330-107015-330-1072020-05-20
00688346000405Fine Osteotomy system - Proximal tibia015-410-002015-410-0022020-05-20
00688346000412Fine Osteotomy system - Proximal tibia015-410-003015-410-0032020-05-20
00688346000429Fine Osteotomy system - Proximal tibia015-410-004015-410-0042020-05-20
00688346000436Fine Osteotomy system - Proximal tibia015-410-005015-410-0052020-05-20
00688346000443Fine Osteotomy system - Proximal tibia015-410-006015-410-0062020-05-20
00688346000450Fine Osteotomy system - Proximal tibia015-410-007015-410-0072020-05-20

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Primary DI, Brand, Company table
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