FDA.reportPublic FDA data

Archimedes Access Kit

Primary DI
00856571007029
Brand
Archimedes Access Kit
Company
BRONCUS MEDICAL INC.
Model
10009
Catalog number
10009
Device description
A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.
Published
2017-06-27
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
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131234000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131234000LUNGPOINT TOOLS (LUNGPOINT SHEATH, LUNGPOINT DILATION BALLOON)Broncus Medical, Inc.2013-10-15EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856571007029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856571007029008565710070298565710070290856571007029

GMDN Terms#

Term, Definition table
TermDefinition
Lung biopsy procedure kitA collection of sterile devices designed to perform a histologic specimen aspiration during a percutaneous lung biopsy. It typically includes a biopsy needle and other supplies to perform this procedure. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-428-1600CustomerSupport@Broncus.com

Regulatory Flags#

DUNS number
078684808
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856571007265EasyPath RF Introducer Sheath100112026-04-23
00856571007913BroncTru™ Transbronchial Access ToolAK-82-702025-03-31
00856571007920BroncTru™ Transbronchial Access ToolAK-64-602025-03-31
00856571007937BroncTru™ Transbronchial Access ToolAK-46-552025-03-31
00856571007944BroncTru™ Transbronchial Access ToolAK-91-552025-03-31
00856571007951BroncTru™ Transbronchial Access ToolAK-82-002025-03-31
00856571007968BroncTru™ Transbronchial Access ToolAK-64-002025-03-31
00856571007975BroncTru™ Transbronchial Access ToolAK-46-002025-03-31
00856571007982BroncTru™ Transbronchial Access ToolAK-91-002025-03-31
08565710078012BioStar Transbronchial Aspiration NeedleiS2372024-08-19
08565710078029BioStar Transbronchial Aspiration NeedleiS2272024-08-19
00856571007296Archimedes Access Kit10009-910009-92021-10-04
00856571007241Empower RF Catheter10010100102019-11-01
00856571007036Archimedes System40005400052017-06-27
00856571007104Archimedes Planning System40009400092017-06-27
00856571007128LungPoint Planning System, v3.230009300092017-06-27
00856571007173LungPoint VBN System, V3.230005300052017-06-27
00856571007227Archimedes Access Key10009-110009-12017-12-12
00856571007258Archimedes Access Key, 10-pack10009-210009-22019-02-21
00856571007012FleXNeedle10005-110005-12017-05-12

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Primary DI, Brand, Company table
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