AccessGUDID - DEVICE: Surgical Direct (B382SD902973000)

GUDID

Device Identifier (DI) Information

Brand Name: Surgical Direct
Version or Model: SD90297300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SD90297300
Company Name: Surgical Direct, Inc.

Primary DI Number: B382SD902973000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 124367223 *Terms of Use

Device Description: Classic-Round Probe Periodontal Se Color Coded Fig 12

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?
35942	Phosphorescent/fibreoptic patient thermometer	A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It uses a fibreoptic probe that includes a small mass temperature sensor, usually based on phosphor fluorescence decay time or other temperature varying physical property, e.g., liquid crystal structure or polarization rotation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIX	Probe, Periodontic

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: bac163e6-8202-4ac0-b17d-3a01e0ffd6e1
Public Version Date: April 17, 2024
Public Version Number: 2
DI Record Publish Date: March 13, 2024

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(386) 738-1202
Email: info@surgicaldirect.com

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