AccessGUDID - DEVICE: Novo Surgical Inc. (00842331138324)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical Inc.
Version or Model: OP7116-23NC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OP7116-23NC
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331138324
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: desmarres lid retractor, insulated, non-conductive, 5 1/2" (14.0 cm), size 1 , 12.0 mm wide

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?
35527	Periocular/lacrimal retractor, self-retaining	A self-retaining, ophthalmic surgical instrument intended to be used to draw aside the margins of a periocular surgical wound, typically to access the nasolacrimal duct/lacrimal sac during an ophthalmic intervention; it is not intended to retract tissues of the eyeball and is not an eyelid speculum. The instrument is typically designed with two conjoined legs and a self-retaining mechanism, and is usually made of stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HNI	Retractor, Ophthalmic

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: be27665b-4cb1-420b-89ab-f66704113e78
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 11, 2022