AccessGUDID - DEVICE: Salvin Dental Specialties (00841336112834)

GUDID

Device Identifier (DI) Information

Brand Name: Salvin Dental Specialties
Version or Model: BLAD-MICRO-64
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BLAD-MICRO-64
Company Name: SALVIN DENTAL SPECIALTIES, LLC

Primary DI Number: 00841336112834
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113344790 *Terms of Use

Device Description: Salvin Bendable Micro-Miniature Surgical Blades - Box of 6

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?
32382	Manual scalpel blade, reusable	An interchangeable device designed to mount a compatible handle and function as the cutting edge of a scalpel. The device is made of high-grade stainless steel alloy and is used as a surgical instrument to cut and dissect tissues. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GES	BLADE, SCALPEL

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: 01b54084-2a8c-4052-917e-c74bda6ee365
Public Version Date: December 19, 2024
Public Version Number: 1
DI Record Publish Date: December 11, 2024