DEVICE: Freehand Ring (00860000626903)

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Device Identifier (DI) Information
Freehand Ring
FR403
In Commercial Distribution

PURA DENTAL PRODUCTS LLC
00860000626903
GS1

1
046937930 *Terms of Use
Freehand Ring platform ring is an autoclavable ring worn on the finger during dental procedures which holds two types of disposable inserts. A foam insert used to remove debris from instrument tips during instrumentation or a well insert used to hold substances that are being applied to the oral cavity.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
No
No
Yes
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
65034 Wearable dental procedure holding ring
A plastic, ring-like device intended to be worn on the finger of a dental professional to accept and hold various dedicated accessories (e.g., instrument cleaning pads, instrument holders, dental substance receptacles) used during a dental procedure. This is a reusable device.
Active false
65035 Wearable dental procedure holding ring cleaning pad
A rough, foam-like device intended for use with (inserted into) a wearable dental procedure holding ring (not included) to clean and remove debris from dental instruments during procedures. This is a single-use device.
Active false
65036 Wearable dental procedure holding ring well
A shallow open receptacle intended for use with (inserted into) a wearable dental procedure holding ring (not included) to hold liquid, paste and gel-like dental substances or other small materials used during procedures. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EJB Handle, Instrument, Dental
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
819de15d-c26d-45be-8d8b-e7cb967a2521
December 25, 2020
1
December 17, 2020
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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