FDA.report

SAMPEDRO

Primary DI
07708604560618
Brand
SAMPEDRO
Company
INDUSTRIAS MEDICAS SAMPEDRO S A S
Model
0
Catalog number
/GPMDAE
Device description
Styloid hole variable angle drill guide
Published
2022-05-10
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

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07708604560618PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07708604560618077086045606187708604560618

GMDN Terms

TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
880314190
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
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 DIBrandModelCatalogPublished
07708604560397SAMPEDRO0TCIAT35162023-02-14
07708604560564SAMPEDRO0TBPA35122023-02-14
07708604560595SAMPEDRO0TCIAT35122023-02-14
07708604560724SAMPEDRO0TBPA35102023-02-14
07708604560779SAMPEDRO0TCIAT35102023-02-14
07708604560885SAMPEDRO0TBPA35142023-02-14
07708604560915SAMPEDRO0TCIAT35142023-02-14
07708604560922SAMPEDRO0TBPA35162023-02-14
07708604560335SAMPEDRO0/CMPRDSAFRD2023-02-03
07708604560908SAMPEDRO0/CMPCTSAFRD2023-02-03
07708434060579SAMPEDRO0TCIAT35652022-05-12
07708434060586SAMPEDRO0TCIAT35502022-05-12
07708434060722SAMPEDRO0TCIAT35552022-05-12
07708434060944SAMPEDRO0TCIAT35602022-05-12
07708604560007SAMPEDRO0/STR132022-05-12
07708604560014SAMPEDRO0/EPCBR2022-05-12
07708604560021SAMPEDRO0TBPA35242022-05-12
07708604560052SAMPEDRO0TCIAT35202022-05-12
07708604560069SAMPEDRO0/PRAR162022-05-12
07708604560076SAMPEDRO0/PACHT8AO2022-05-12

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