FDA.reportPublic FDA data

TraceIT Tissue Marker 1-UP

Primary DI
00864661000119
Brand
TraceIT Tissue Marker 1-UP
Company
AUGMENIX, INC.
Model
TH-1011
Catalog number
TH-1011
Device description
TraceIT® Tissue Marker is a sterile, single use, product consisting of a pre-filled glass syringe containing the synthetic, radiopaque cross-linked PEG hydrogel with an endcap.
Published
2015-12-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121964000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121964000MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10MLAugmenix, Inc.2013-01-23NEU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00864661000119PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00864661000119008646610001198646610001190864661000119

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, implantableA sterile device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiographic film or digital images. It is typically formed as a wire, needle, bead, stent-like tube or washer, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature60 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
960905862
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864661000133TraceIT Tissue Marker 3mL 1-UPTH-1031TH-10312015-12-10
10864661000116TraceIT Tissue Marker 5-UPTH-1015TH-10152015-12-11
10864661000130TraceIT Tissue Marker 3mL 5-UPTH-1035TH-10352015-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450392867SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392874SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392881SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392935SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392942SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392959SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
00884450392966SCOUT MD™Merit Medical Systems, Inc.NEU2026-05-28
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10851674008604SmartClip SecureElucent Medical, Inc.NEU2026-02-16
10851674008468SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008475SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008482SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008499SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008505SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008512SmartClipElucent Medical, Inc.NEU2025-10-01
10851674008529SmartClipElucent Medical, Inc.NEU2025-10-01
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10851674008543SmartClipElucent Medical, Inc.NEU2025-10-01
00801741226335UltraCor™ Twirl™Bard Peripheral Vascular, Inc.NEU2025-04-01
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08719992742516Sirius PintuitionSirius Medical Systems B.V.NEU2024-11-22
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