FDA.reportPublic FDA data

SAMPEDRO

Primary DI
07708604560113
Brand
SAMPEDRO
Company
INDUSTRIAS MEDICAS SAMPEDRO S A S
Model
0
Catalog number
/ST16
Device description
Inge 16,0cm
Published
2022-05-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWNInstrument, Compression

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07708604560113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07708604560113077086045601137708604560113

GMDN Terms#

Term, Definition table
TermDefinition
Bone approximation clampA hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
880314190
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07708626670869SAMPEDRO0/IMP62022-05-12
07708604560892SAMPEDRO0/GAFF2022-05-12
07708626670081SAMPEDRO0/DPGD-W42022-05-12
07708626670289SAMPEDRO0/DPGI-W42022-05-12
07708626670159SAMPEDRO0/SH242022-05-12
07708626670906SAMPEDRO0/SH2852022-05-12
07708604560397SAMPEDRO0TCIAT35162023-02-14
07708604560564SAMPEDRO0TBPA35122023-02-14
07708604560595SAMPEDRO0TCIAT35122023-02-14
07708604560724SAMPEDRO0TBPA35102023-02-14
07708604560779SAMPEDRO0TCIAT35102023-02-14
07708604560885SAMPEDRO0TBPA35142023-02-14
07708604560915SAMPEDRO0TCIAT35142023-02-14
07708604560922SAMPEDRO0TBPA35162023-02-14
07708434060579SAMPEDRO0TCIAT35652022-05-12
07708434060586SAMPEDRO0TCIAT35502022-05-12
07708434060722SAMPEDRO0TCIAT35552022-05-12
07708434060944SAMPEDRO0TCIAT35602022-05-12
07708604560021SAMPEDRO0TBPA35242022-05-12
07708604560052SAMPEDRO0TCIAT35202022-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWN2026-03-30
00840311245451Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-03-18
00810111226691Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-02-20
00818345029774RIVA Posterior Fixation SystemXENIX MEDICAL LLCHWN2026-01-12
00810111226677Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226684Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
00810111226707Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-01-05
15060238201596Femoral Cement PressuriserSUMMIT MEDICAL LIMITEDHWN2025-01-10
00840298704637Songer® Spinal Cable SystemPioneer Surgical Technology, Inc.HWN2024-08-23
00643169350991Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWN2022-10-08
G079C5060000010Golden Isles Pedicle Screw SystemIntelivation, LLCHWN2022-09-23
00613994878137n/aMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
00721902875755N/AMEDTRONIC SOFAMOR DANEK, INC.HWN2022-08-06
20886982313437NASynthes GmbHHWN2022-07-29
20886982313444NASynthes GmbHHWN2022-07-29
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20886982313499NASynthes GmbHHWN2022-07-29
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20886982313512NASynthes GmbHHWN2022-07-29
20886982313529NASynthes GmbHHWN2022-07-29
20886982313536NASynthes GmbHHWN2022-07-29