AccessGUDID - DEVICE: Power Dental U.S.A., Inc. (D943N5417)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental U.S.A., Inc.
Version or Model: N5417
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: N5417
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D943N5417
Issuing Agency: HIBCC
Commercial Distribution End Date: December 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: NEEDLE HOLDER MATHIEU 14cm / 5.5inch OT-8015N

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":	Yes
For Single-Use:	No
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?
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: fe6ab0cb-1ac3-4481-a941-7e24e3da6e58
Public Version Date: December 20, 2022
Public Version Number: 2
DI Record Publish Date: June 20, 2021