FDA.report

Instrapac

Primary DI
05010058184701
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8470
Catalog number
8470
Device description
Instrapac Dental Luxation Instrument 3C (3mm Curved) x 10
Published
2025-06-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EMJElevator, Surgical, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058184701PackageGS110In Commercial Distribution
05010058084704PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058184701050100581847015010058184701
05010058084704050100580847045010058084704

GMDN Terms

TermDefinition
Periotome, single-useA 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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep out of direct sunlight

Sterilization Methods

Method

Contacts

PhoneEmail
+441909735502ASKVCI@vernacare.com

Regulatory Flags

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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