AccessGUDID - DEVICE: DENTAL PROBE (B974DP10200)

GUDID

Device Identifier (DI) Information

Brand Name: DENTAL PROBE
Version or Model: DENTAL PROBE
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DP1020
Company Name: DR.FRIGZ INTERNATIONAL(PVT)LTD,

Primary DI Number: B974DP10200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 645680125 *Terms of Use

Device Description: DENTAL PROBE WITH ONE SIDE MARKED 6 INCH

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):	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?
63722	Ophthalmic soft-tissue surgical forceps probe-tip, single-use	A sterile distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKB	Explorer, Operative

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 [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 6 Inch

Device Record Status

Public Device Record Key: 0e3d012a-25c2-49be-9949-64b71dff45ad
Public Version Date: November 29, 2022
Public Version Number: 1
DI Record Publish Date: November 21, 2022