AccessGUDID - DEVICE: Henry Schein (00304040029435)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1005646
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1005646
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040029435
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Chairside Reline Material Pack Ea

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:	Yes
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?
34769	Denture reliner, elastic, short-term	A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	RESIN, DENTURE, RELINING, REPAIRING, REBASING

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
Special Storage Condition, Specify: Keep out of sun
Storage Environment Temperature: between 50 and 75 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Bottle
Total Volume: 110 Milliliter
Weight: 100 Gram

Device Record Status

Public Device Record Key: d8a734f1-3ce8-4483-aeff-c96ba3027f96
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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