NA

Primary DI
10705034707266
Brand
NA
Company
Synthes GmbH
Model
SD388.832
Catalog number
SD388832
Device description
BI-PLANAR PERSUADER
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTCPLIERS, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTCPliers, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034707266PrimaryGS10
H981SD3888320SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503470726610705034707266

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic rod reducerA heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887587060743ChronOS710.000.98S71000098S2015-09-14
10887587060774ChronOS710.003.98S71000398S2015-09-14
10887587060781ChronOS710.011.98S71001198S2015-09-14
10886982228185NA456.456S456456S2015-09-14
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8034802690ORTHOMEDORTHO-MED, INC.HTC2026-04-16
B8034803700ORTHOMEDORTHO-MED, INC.HTC2026-04-16
B8034803720ORTHOMEDORTHO-MED, INC.HTC2026-04-16
B8034709310ORTHOMEDORTHO-MED, INC.HTC2026-03-30
00840105223818ZOLL DENTALZoll-DentalHTC2025-09-16
00840105223825ZOLL DENTALZoll-DentalHTC2025-09-16
00840105223832ZOLL DENTALZoll-DentalHTC2025-09-16
10887587077628NASynthes GmbHHTC2024-08-21
B356KJ666140American MedicalsAmerican MedicalsHTC2024-07-11
10840199539458ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199539489ForcepKOROS U.S.A., INC.HTC2024-02-01
10840199535900ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535962C ClampKOROS U.S.A., INC.HTC2024-01-31
10840199535993Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
10840199536006Aortic ClampKOROS U.S.A., INC.HTC2024-01-31
B356KJ526120American MedicalsAmerican MedicalsHTC2022-12-14
14026704799135PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799142PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799159PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799166PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799319PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799326PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704811448PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
10840199539830ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539847ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539854ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539861ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539878ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539885ForcepsKOROS U.S.A., INC.HTC2022-10-31
10840199539892ForcepsKOROS U.S.A., INC.HTC2022-10-31