AccessGUDID - DEVICE: SCOTT'S PREMIUM GERMAN EXTRACTION FORCEP # 35 (D778190F350)

GUDID

Device Identifier (DI) Information

Brand Name: SCOTT'S PREMIUM GERMAN EXTRACTION FORCEP # 35
Version or Model: 190-F35
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 190-F35
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D778190F350
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: SCOTT'S PREMIUM GERMAN EXTRACTION FORCEP # 35

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?
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
DZN	INSTRUMENTS, DENTAL HAND

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: c93622d4-bb6a-4b9c-a397-05dc311088ec
Public Version Date: March 08, 2021
Public Version Number: 1
DI Record Publish Date: February 27, 2021