AccessGUDID - DEVICE: Novo Surgical Inc. (00842331166761)

GUDID

Device Identifier (DI) Information

Brand Name: Novo Surgical Inc.
Version or Model: C6636-47
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C6636-47
Company Name: NOVO SURGICAL, INC.

Primary DI Number: 00842331166761
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 033029433 *Terms of Use

Device Description: jacobson micro needle holder, round handle, jaw surfaces impregnated w/ fine tungsten carbide dust (use w/ 5-0, 6-0 suture), straight w/ lock, 9 1/8" (23.5 cm)

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?
12726	Suturing needle holder, reusable	A hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FHQ	Holder, Needle, Gastroenterologic

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: db910d46-111b-4089-bde8-e8ae62e8756b
Public Version Date: November 21, 2022
Public Version Number: 1
DI Record Publish Date: November 13, 2022