AccessGUDID - DEVICE: Amcop Bioactivator (EMICB0S1DEEP1)

GUDID

Device Identifier (DI) Information

Brand Name: Amcop Bioactivator
Version or Model: B0S1-DEEP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B0S1-DEEP
Company Name: MICERIUM SPA

Primary DI Number: EMICB0S1DEEP1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 436661136 *Terms of Use

Device Description: Amcop Bioactivator BIOACTIVATOR 1 pc. Class I Mod. 0S DEEP Size 1 - 45 mm

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?
35310	Orthodontic retainer	An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMY	Positioner, Tooth, 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: eb4d3ade-8140-4f7f-be2c-3d57d4ef8a22
Public Version Date: March 25, 2025
Public Version Number: 1
DI Record Publish Date: March 17, 2025

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

Customer Contact

[?]

No Customer Contact currently defined

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