FDA.reportPublic FDA data

BiomarC ®

Primary DI
00858015005646
Brand
BiomarC ®
Company
Carbon Medical Technologies, Inc.
Model
040143
Catalog number
040143
Device description
Coaxial Needle
Published
2016-10-12
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBKEndoscopic Injection Needle, Gastroenterology-Urology
NEUMarker, Radiographic, Implantable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2
NEUMarker, Radiographic, ImplantableGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133148000BIOMARC COAXIAL NEEDLECarbon Medical Technologies, Inc.2014-05-13FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858015005646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858015005646008580150056468580150056460858015005646

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, single-useA rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8.5Centimeter
Needle Gauge18Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8882070262info@carbonmed.com

Regulatory Flags#

DUNS number
883094039
Device count
1
DM exempt
true
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
00850002461046Carbon Bright®0401510401512020-01-08
00850002461053Carbon Bright®0401520401522020-01-08
00850002461060Carbon Bright ®0401530401532020-02-18
00850002461077Carbon Bright ®0401540401542020-02-18
00850002461305BIOMARC ® EX0401650401652022-02-07
00850002461343BiomarC®0401670401672024-07-23
00850002461350Carbon Bright ®0401660401662024-07-23
00858015005059BiomarC®0401400401402015-08-07
00858015005066BiomarC ®0401010401012015-08-18
00858015005073BiomarC ®0401330401332015-08-18
00858015005080BiomarC ®0401420401422015-08-18
00858015005097BiomarC®0404000404002015-08-24
00858015005103BiomarC®0404010404012015-08-24
00858015005110BiomarC®0404020404022015-08-24
00858015005127BiomarC®0401090401092015-09-24
00858015005134BiomarC®0401150401152015-09-24
00858015005141BiomarC®0401190401192015-09-24
00858015005158BiomarC®0401200401202015-09-24
00858015005172BiomarC®0401220401222015-09-24
00858015005189BiomarC®0401230401232015-09-24

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