NA

Primary DI
07611819718586
Brand
NA
Company
Synthes GmbH
Model
388.506
Catalog number
388506
Device description
ROD INTRODUCTION PLIERS FOR DUAL-OPENING IMPLANTS
Published
2016-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
07611819718586Direct MarkingGS10
10705034773322PrimaryGS10
H9813885060SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819718586076118197185867611819718586
1070503477332210705034773322

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

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00840105223825ZOLL DENTALZoll-DentalHTC2025-09-16
00840105223832ZOLL DENTALZoll-DentalHTC2025-09-16
10887587077628NASynthes GmbHHTC2024-08-21
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10840199539489ForcepKOROS U.S.A., INC.HTC2024-02-01
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14026704799166PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
14026704799319PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
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14026704811448PILLINGTELEFLEX INCORPORATEDHTC2022-12-08
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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