FDA.report

Stellar Medical

Primary DI
00853162006072
Brand
Stellar Medical
Company
STELLAR MEDICAL, LLC
Model
0834SM
Device description
4, 18 ga x 20 cm needles, each containing 1, 0.8 x 3.0 mm gold marker, St
Published
2016-08-17
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

Related Records

Product Codes

CodeName
KXKSource, Brachytherapy, Radionuclide

Product Code Classifications

CodeDeviceSpecialtyClass
KXKSource, Brachytherapy, RadionuclideRadiology2

Premarket Submissions

SubmissionSupplement
K092041000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K092041000STELLAR FIDUCIAL MARKER, MODEL GFMIAStellar Medical, LLC2009-10-02IYE

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00853162006072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853162006072008531620060728531620060720853162006072

GMDN Terms

TermDefinition
Brachytherapy needleA sterile, 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.

Sterilization Methods

Method
Ethylene Oxide

Regulatory Flags

DUNS number
015116092
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00853162006508Stellar MedicalL1055SM2019-05-15
00853162006515Stellar MedicalL1035SM2019-05-15
00853162006522Stellar Medical123430SM2019-05-15
00853162006539Stellar Medical12104SM2019-05-15
00853162006546Stellar Medical1210430SM2019-05-15
00853162006553Stellar Medical10104SM2019-05-15
00853162006560Stellar MedicalL08325SM2019-05-15
00853162006003Stellar Medical0451SM2016-08-17
00853162006010Stellar Medical08101SM2016-08-17
00853162006027Stellar Medical08103SM2016-08-17

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