AccessGUDID - DEVICE: Power Dental USA (D9432813SPG00)

GUDID

Device Identifier (DI) Information

Brand Name: Power Dental USA
Version or Model: 1280
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1280
Company Name: Power Dental U.S.A. Inc.

Primary DI Number: D9432813SPG00
Issuing Agency: HIBCC
Commercial Distribution End Date: June 16, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 081305064 *Terms of Use

Device Description: ASDF

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?
11791	Dressing/utility forceps, scissors-like, reusable	A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.	Active	false
43999	Bone graft syringe, single-use	A calibrated barrel (cylinder) with plunger intended to be used to aspirate bone graft materials (e.g., autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic/composite bone matrix graft materials) and deliver them to a surgical site during an orthopaedic, oral, or maxillofacial surgical procedure. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EID	SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL

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: fa3ac94a-4dee-46fc-99f8-fdc8b2894d7f
Public Version Date: June 17, 2022
Public Version Number: 3
DI Record Publish Date: July 13, 2021