AccessGUDID - DEVICE: Pediatric Grooved Tip Sucker (B0662010360000)

GUDID

Device Identifier (DI) Information

Brand Name: Pediatric Grooved Tip Sucker
Version or Model: 201036-000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 201036-000
Company Name: NOVOSCI CORP.

Primary DI Number: B0662010360000
Issuing Agency: HIBCC
Commercial Distribution End Date: June 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 938289980 *Terms of Use

Device Description: A hand-held device designed to regulate and direct a stream of pressurized fluid (e.g., sterile water or saline) and as an alternative provide aspiration (suction), to a surgical site, for the purpose of irrigating and clearing debris from the field of intervention. It is fitted with a long syringe-like nozzle that is activated by the user, typically through a push-type control(s). This device is typically a component of a surgical irrigation/aspiration system used for ENT or neurological surgery. 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):	No
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?
60793	Surgical irrigation/aspiration handpiece, single-use	A hand-held device designed to be connected to a separate cannula/tip for both irrigation and aspiration of a surgical site by regulating and directing a stream of pressurized fluid (e.g., sterile water) to the site and facilitating suction of debris from the site. It is activated by the operator, typically through a push-type control(s); it may include connection tubing, however other associated devices (e.g., cannula/tip, clamps, filters, spikes) are not included (i.e., it is neither a tubing set nor an irrigation/aspiration cannula). It is typically intended for an ear/nose/throat (ENT) procedure or neurosurgical use; it is not an ophthalmic device. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K801400	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2ce9b764-42dd-4afb-b32e-fa5fac4b8109
Public Version Date: June 21, 2023
Public Version Number: 6
DI Record Publish Date: September 26, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
B0662010360006	100	B0662010360000	2023-06-20	Not in Commercial Distribution	Case
B0662010360005	75	B0662010360000	2023-06-20	Not in Commercial Distribution	Partial Case
B0662010360004	50	B0662010360000	2023-06-20	Not in Commercial Distribution	Partial Case
B0662010360003	25	B0662010360000	2023-06-20	Not in Commercial Distribution	Inner Carton