FDA.reportPublic FDA data

AdvantageRib

Primary DI
00854865007434
Brand
AdvantageRib
Company
SIG MEDICAL CORP.
Model
323.0055
Catalog number
323.0055
Device description
AdvantageRib Folding Clamp
Published
2018-10-03
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141241000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141241000MATRIXRIB ENDO THORACOSCOPIC RIB PLATING SYSTEMSynthes (USA) Products, LLC2014-08-07HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854865007434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854865007434008548650074348548650074340854865007434

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
717-553-2021info@sigmedical.net

Regulatory Flags#

DUNS number
080503619
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854865007489AdvantageRib323.1010323.10102019-08-20
00854865007496AdvantageRib323.1011323.10112019-08-20
00854865007502AdvantageRib323.1012323.10122019-08-20
00854865007519AdvantageRib323.1013323.10132019-08-20
00854865007526AdvantageRib323.1020323.10202019-08-20
00854865007533AdvantageRib323.1021323.10212019-08-20
00854865007540AdvantageRib323.1022323.10222019-08-20
00854865007557AdvantageRib323.1023323.10232019-08-20
00854865007564AdvantageRib323.1030323.10302019-08-20
00854865007571AdvantageRib323.1031323.10312019-08-20
00854865007588AdvantageRib323.1032323.10322019-08-20
00854865007595AdvantageRib323.1033323.10332019-08-20
00854865007007AdvantageRib323.1001323.10012018-10-03
00854865007014AdvantageRib323.1002323.10022018-10-03
00854865007021AdvantageRib323.1003323.10032018-10-03
00854865007038AdvantageRib323.1004323.10042018-10-03
00854865007045AdvantageRib323.1005323.10052017-02-17
00854865007052AdvantageRib323.1006323.10062017-02-17
00854865007069AdvantageRib323.1007323.10072017-02-17
00854865007076AdvantageRib104.517.0102017-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
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00850080543047PC Fix Extrathoracic Plate 95mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEKChest Wall Innovations, Inc.HRS2026-06-01