DEVICE: Instrapac (05010058084711)

Device Identifier (DI) Information

Instrapac
8471
In Commercial Distribution
8471
ROBINSON HEALTHCARE LIMITED
05010058084711
GS1

1
237799775 *Terms of Use
Instrapac Dental Luxation Instrument 5S (5mm Straight) x 10
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
No
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?
45700 Periotome, single-use
A hand-held dental instrument intended to be used during tooth extraction/luxation to cut the periodontal ligament that binds the tooth to the surrounding marginal and alveolar bone (alveolar process), causing minimal mechanical trauma to the bone tissue. It is typically made of stainless steel and consists of a shaft that terminates in a single or double flat, sharpened blade that is straight, curved, or angled. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
EMJ Elevator, Surgical, Dental
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Keep dry and keep out of direct sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 5S (5mm Straight)
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Device Record Status

6888d560-f484-4b74-88f4-dc7663657788
July 01, 2025
1
June 23, 2025
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
05010058184718 10 05010058084711 In Commercial Distribution Box
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Secondary DI

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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+441909735502
ASKVCI@vernacare.com
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