AccessGUDID - DEVICE: Keystone Industries (H66812710901)

GUDID

Device Identifier (DI) Information

Brand Name: Keystone Industries
Version or Model: 1271090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1271090
Company Name: Keystone Industries

Primary DI Number: H66812710901
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 073503117 *Terms of Use

Device Description: #9 Pre-Formed Clasp Pkg 10

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:	Yes
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?
38585	Denture clasp, metal, preformed	A prefabricated dental device typically made of metal alloy, sometimes in wire form, intended to retain and stabilize a removable partial denture to stationary teeth. It is manufactured to meet a standard specification for adaptation or direct insertion into the patient's mouth.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EHP	CLASP, PREFORMED

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: No

Sterilization Method [?]
No Sterilization Methods Found

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: 0b6e57fc-3207-4314-9cf1-2720bd0877b9
Public Version Date: December 08, 2022
Public Version Number: 1
DI Record Publish Date: November 30, 2022

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: H66812710900 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(800)333-3131 ext: 8455
Email: tschwear@keystoneind.com

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