AccessGUDID - DEVICE: Novo Surgical (G586E7248830)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical
Version or Model: E7248-83
Commercial Distribution Status: In Commercial Distribution
Catalog Number: E7248-83
Company Name: NOVO SURGICAL, INC.

Primary DI Number: G586E7248830
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: saunders-paparella stapes hook, angled 90 degrees, malleable shaft, 6 1/2" (16.5 cm), #2, 0.50 mm tips

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?
13039	Middle ear pick	A fine, hand-held manual surgical instrument intended to be used to manipulate the structures of the middle ear (e.g., the stapes). It is typically comprised of a proximal handle that tapers to a shaft which terminates in a fine distal tip bent at 90 degrees to the shaft. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JYL	HOOK, MICROSURGICAL EAR

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: abb1b620-2eaa-4440-9d7d-002c1806f882
Public Version Date: December 26, 2023
Public Version Number: 1
DI Record Publish Date: December 18, 2023