AccessGUDID - DEVICE: Novo Surgical (G586OP7131250)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: OP7131-25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OP7131-25
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586OP7131250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: crawford lacrimal intubation set, 2 olive tip stainless steel probes (6") w/ 11 3/4" of silicone tubing attached

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:	No
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?
47929	Lacrimal intubation set	A collection of devices intended to be used to maintain patency of the nasolacrimal system typically for treating/preventing pathologies of the tear drainage system (e.g., post-chemotherapy stenosis) or after dacryocystorhinostomy (DCR). It consists of a long and flexible bicanalicular or monocanalicular tube (e.g., Crawford type) inserted through the lacrimal puncta into the canaliculi, lacrimal sac, and/or nasolacrimal duct; devices to assist the intubation procedure are typically provided preassembled to the tube (e.g., cannula, probes, bougies, introducer, stylet). The tube is typically left in place long-term before removal. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNL	Probe, lachrymal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: af345f8b-62e2-4789-9425-27f2baac7113
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023