FDA.reportPublic FDA data

PointCoil™

Primary DI
00853730006152
Brand
PointCoil™
Company
CORTEX MANUFACTURING INC.
Model
PC-0.8-1-5-GG-18-5
Device description
Implanted Marker in Needle
Published
2015-08-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100267000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100267000FLEXIMARC, MODEL CM-0.9-2-10-GG-LCortex Manufacturing, Inc.2010-02-24IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00853730006152PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00853730006152008537300061528537300061520853730006152

GMDN Terms#

Term, Definition table
TermDefinition
Brachytherapy injection needleA sharp bevel-edged, hollow tubular metal instrument that is used to inject radionuclide into a body cavity or tissue as a source of nuclear radiation for cancer therapy (brachytherapy). The device may be pre-sterilized and preloaded, and may have a tip enhanced for ultrasound-guided implantation. This is a single-use device.

Regulatory Flags#

DUNS number
832596816
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00853730006008FlexiMarc™FM-0.9-2-10-GG-18-202015-08-24
00853730006015FlexiMarc™FM-0.9-3-10-GG-18-202015-08-24
00853730006022FlexiMarc™FM-1.2-2-10-GG-17-202015-08-24
00853730006039FlexiMarc™FM-1.2-3-10-GG-17-202015-08-24
00853730006046FlexiCoil™FC-0.6-2-10-GG-20-202015-08-24
00853730006053FlexiCoil™FC-0.9-2-10-GG-18-202015-08-24
00853730006060FlexiCoil™FC-0.9-2-20-GG-18-202015-08-24
00853730006077FlexiCoil™FC-1.2-2-10-GG-17-202015-08-24
00853730006084FlexiCoil™FC-1.2-2-20-GG-17-202015-08-24
00853730006091FlexiMarc G/T™FM-1.0-2-10-GT-18-202015-08-24
00853730006107FlexiMarc G/T™FM-1.0-2-20-GT-18-202015-08-24
00853730006114FlexiMarc G/T™FM-1.2-2-10-GT-17-202015-08-24
00853730006121FlexiMarc G/T™FM-1.2-2-20-GT-17-202015-08-24
00853730006138PointCoil™PC-0.6-1-5-GG-20-202015-08-24
00853730006145PointCoil™PC-0.8-1-5-GG-NL2015-08-24
00853730006169PointCoil™PC-0.9-1-5-GG-18-202015-08-24
00853730006176PolyMark™PM-1.0-3-18-202015-08-24
00853730006183PolyMark™PM-1.0-5-18-202015-08-24
00853730006190PolyMark™PM-1.0-3-18-252015-08-24
00853730006206FusionCoil™FC-1.0-5-18-202015-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850065937007eMotusEMPNIA INC.IYE2026-09-21
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00850065937083eMotusEMPNIA INC.IYE2026-09-21
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00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
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00850065937243eMotusEMPNIA INC.IYE2026-09-21
00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
00850065937298eMotusEMPNIA INC.IYE2026-09-21
00850065937304eMotusEMPNIA INC.IYE2026-09-21