DEVICE: Instrapac (05010058084711)
Device Identifier (DI) Information
Instrapac
8471
In Commercial Distribution
8471
ROBINSON HEALTHCARE LIMITED
8471
In Commercial Distribution
8471
ROBINSON HEALTHCARE LIMITED
Instrapac Dental Luxation Instrument 5S (5mm Straight) x 10
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
EMJ | Elevator, Surgical, Dental |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Keep dry and keep out of direct sunlight |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 5S (5mm Straight) |
Device Record Status
6888d560-f484-4b74-88f4-dc7663657788
July 01, 2025
1
June 23, 2025
July 01, 2025
1
June 23, 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 |
---|---|---|---|---|---|
05010058184718 | 10 | 05010058084711 | 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)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+441909735502
ASKVCI@vernacare.com
ASKVCI@vernacare.com