AccessGUDID - DEVICE: Salvin Dental Specialties (00841336108257)

GUDID

Device Identifier (DI) Information

Brand Name: Salvin Dental Specialties
Version or Model: INDIV-YOUNG-FORCEP-TIPS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: INDIV-YOUNG-FORCEP-TIPS
Company Name: SALVIN DENTAL SPECIALTIES, LLC

Primary DI Number: 00841336108257
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113344790 *Terms of Use

Device Description: Tips For Salvin Young Forcep Tips - Set of 2

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):	Yes
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?
35552	Tooth extraction forceps	A hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTD	FORCEPS

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: 12d02acb-1c3f-41e2-886f-61ab5b34e45c
Public Version Date: December 19, 2024
Public Version Number: 1
DI Record Publish Date: December 11, 2024