AccessGUDID - DEVICE: NEEDLE, AIR ASPIRATOR 16 GA W/BLUE CAP (B066201005NS1)

GUDID

Device Identifier (DI) Information

Brand Name: NEEDLE, AIR ASPIRATOR 16 GA W/BLUE CAP
Version or Model: 201005NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 201005NS
Company Name: NOVOSCI CORP.

Primary DI Number: B066201005NS1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 500
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: A sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

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?
35886	Body aspiration needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DWS	Instruments, Surgical, Cardiovascular

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K801393	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1e8cf624-e0d8-4088-9ff5-4041893d3579
Public Version Date: July 13, 2023
Public Version Number: 5
DI Record Publish Date: October 30, 2015

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B066201005NS6	100	B066201005NS1	In Commercial Distribution	Partial Case
B066201005NS5	200	B066201005NS1	In Commercial Distribution	Partial Case
B066201005NS4	250	B066201005NS1	In Commercial Distribution	Partial Case
B066201005NS3	300	B066201005NS1	In Commercial Distribution	Partial Case
B066201005NS2	400	B066201005NS1	In Commercial Distribution	Partial Case