FDA.reportPublic FDA data

SAMPEDRO

Primary DI
07708626670777
Brand
SAMPEDRO
Company
INDUSTRIAS MEDICAS SAMPEDRO S A S
Model
0
Catalog number
/SSMPR
Device description
Senn-Miller Retractor 16cm (blunt)
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
HWOSkid, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWOSkid, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07708626670777PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07708626670777077086266707777708626670777

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system mounting frame, reusableA noninvasive mounting device (e.g., a large ring, table-fixed bridging bar) designed as a component of a surgical retraction system, intended to be placed/fixed around a surgical incision site and upon which retraction system blades/components are mounted to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during surgery. It does not include the invasive retraction blades/components (i.e., is not the complete system). 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
00194613124106MSI Precision Specialty InstrumentsMed Saver, Inc.HWO2025-08-01
G586N98822010Novo SurgicalNOVO SURGICAL, INC.HWO2023-12-18
07708604560205SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2023-01-18
07708604560359SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2023-01-18
00842331138850Novo Surgical Inc. NOVO SURGICAL, INC.HWO2022-11-11
07708604560014SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708604560106SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670159SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708626670906SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-12
07708604560038SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHWO2022-05-09
00190776183660MillenniumAvalign Technologies, Inc.HWO2021-11-01
10381780183372Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
10381780433972Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
M2742254251Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
M2742254201Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-24
10381780427179Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-10
H834276800Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWO2018-01-10
00889024066724NAZimmer, Inc.HWO2017-05-09
00889024066717NAZimmer, Inc.HWO2016-07-27