AccessGUDID - DEVICE: Henry Schein (H65810446810)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 1044681
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1044681
Company Name: HENRY SCHEIN, INC.

Primary DI Number: H65810446810
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Maxicide Activated

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?
40579	Glutaraldehyde device sterilant	A liquid substance that includes glutaraldehyde as its primary agent intended to completely destroy or eliminate (sterilize) all harmful microorganisms on a medical device (e.g., surgical or dental instrument); it may also be intended for use as a high-level disinfectant. The medical device is typically bathed by the substance for a specified period of time in order to achieve high-level disinfection or sterilization. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MED	Sterilant, medical devices

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K914749	000

Device Exempt from Premarket Submission: No 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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Do not freeze

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b8880bf-0710-4d3a-b4bb-658c875ca59a
Public Version Date: July 06, 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
H65810446811	4	H65810446810		In Commercial Distribution	Box

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: Yes
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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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