AccessGUDID - DEVICE: Archimedes Access Kit (00856571007029)

GUDID

Device Identifier (DI) Information

Brand Name: Archimedes Access Kit
Version or Model: 10009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10009
Company Name: BRONCUS MEDICAL INC.

Primary DI Number: 00856571007029
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078684808 *Terms of Use

Device Description: A collection of sterile devices designed to access and perform a biopsy sample during a lung biopsy.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38562	Lung biopsy procedure kit	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOQ	Bronchoscope (Flexible Or Rigid)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K131234	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Room Temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8fbd0541-50a6-4c3a-be63-165a78358a0f
Public Version Date: February 22, 2019
Public Version Number: 4
DI Record Publish Date: June 27, 2017