AccessGUDID - DEVICE: Surgical Direct (B382SD9200511070)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD920051107
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD920051107
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD9200511070
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: 1 5/8" Gruber Infant Speculum, 3.8mm

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):	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?
33395	Ear speculum, reusable	A rigid plastic or metal tube that is cone-shaped (i.e., it tapers down from a standard instrument fitting size to a small opening) and is either hand-held and manually inserted, or fitted onto a compatible otoscope, and then inserted into the ear canal to create a channel for examination, suction, irrigation, or the insertion of another surgical device during an ear/nose/throat (ENT) procedure. It may in addition be intended for use with an audiometer and might also be referred to as an ear cannula or probe. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGN	SCISSORS, SURGICAL TISSUE, DENTAL

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: c25e2c87-ad58-4c8a-875e-48c58a557efc
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: March 26, 2024