FDA.reportPublic FDA data

SAMPEDRO

Primary DI
07708604560069
Brand
SAMPEDRO
Company
INDUSTRIAS MEDICAS SAMPEDRO S A S
Model
0
Catalog number
/PRAR16
Device description
Bone Holding Forceps, 16cm
Published
2022-05-12
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
HXKHolder, Needle; Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXKHolder, Needle; OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07708604560069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07708604560069077086045600697708604560069

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
00810158219625PRINCETONPrinceton Medical Group, Inc.HXK2026-04-22
00810158216778PRINCETONPrinceton Medical Group, Inc.HXK2026-04-20
09348811016249INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
09348811016379INKAThe Trustee for KAISER FAMILY TRUSTHXK2025-11-19
B356DF410180American MedicalsAmerican MedicalsHXK2025-11-10
B7685135310Buxton BioMedicalBuxton Biomedical IncHXK2025-11-03
04052536007899neon3Ulrich GmbH & Co. KGHXK2025-11-03
00810158217454PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00810158217461PRINCETONPrinceton Medical Group, Inc.HXK2025-10-08
00840314251268gSourceGSOURCE LLCHXK2025-09-21
10649111488146Sklar InstrumentsSKLAR CORPORATIONHXK2025-05-23
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