FDA.reportPublic FDA data

NA

Primary DI
10885403088957
Brand
NA
Company
Bard Peripheral Vascular, Inc.
Model
CHI226
Catalog number
CHI226
Device description
Chiba Fine Needle Aspiration 22G X 6CM
Published
2018-07-18
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
GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885403088955PackageGS110In Commercial Distribution
10885403088957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088540308895550885403088955
1088540308895710885403088957

GMDN Terms#

Term, Definition table
TermDefinition
Cell-block cytology aspiration needleA sterile, sharp bevel-edged, hollow tubular metal instrument, combined with a Luer connector containing an absorbent foam pad, intended to be used for the collection of a biopsy specimen by fine needle aspiration (FNA) and to enable cells in a fluid specimen to be incorporated into a cell block; it is not dedicated to a particular part of the anatomy. Cells from the aspirate are captured in the foam pad enabling processing and analysis of the specimen using techniques typically applied to solid tissue specimens (e.g., paraffin processing, histological sectioning, immunohistochemistry, in situ hybridization). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length6Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)321-4254Customer_Support@BD.com

Regulatory Flags#

DUNS number
135057938
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00801741032011SenoMark® Ultra Breast Tissue MarkerSMEC7RSMEC7R2015-10-02
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00801741032035SenoMark® Ultra Breast Tissue MarkerSMEC10RSMEC10R2015-10-01
00801741032042SenoMark® Ultra Breast Tissue MarkerSMEC12CSMEC12C2015-10-01
00801741032059SenoMark® Ultra Breast Tissue MarkerSMEC12RSMEC12R2015-10-02
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00801741032073SenoMark® Ultra Breast Tissue MarkerSMMA11RSMMA11R2015-10-01
00801741032080SenoMark® Ultra Breast Tissue MarkerSMAT9CSMAT9C2015-10-02
00801741032097SenoMark® Ultra Breast Tissue MarkerSMAT9RSMAT9R2015-10-02
00801741032103SenoMark® Ultra Breast Tissue MarkerSMAT12CSMAT12C2015-10-01
00801741032110SenoMark® Ultra Breast Tissue MarkerSMAT12RSMAT12R2015-10-01
00801741032127SenoMark® Ultra Breast Tissue MarkerSMEV9CSMEV9C2015-10-02
00801741032134SenoMark® Ultra Breast Tissue MarkerSMEV9RSMEV9R2015-10-02
00801741032219UltraClip® Dual Trigger Breast Tissue Marker862017D862017D2015-09-25
00801741032226UltraClip® Dual Trigger Breast Tissue Marker862017DL862017DL2015-09-25
00801741032233UltraClip® Dual Trigger Breast Tissue Marker863017D863017D2015-09-25
00801741032240UltraClip® Dual Trigger Breast Tissue Marker863017DL863017DL2015-09-25
00801741032257UltraClip® Dual Trigger Breast Tissue Marker864017D864017D2015-09-25

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
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10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
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