FDA.report

Instrapac

Primary DI
05010058184657
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8465
Catalog number
8465
Device description
Instrapac Extraction Forceps No 76N Fine Upper Root X10
Published
2025-05-21
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
EMGForceps, Tooth Extractor, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
EMGForceps, Tooth Extractor, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05010058184657PackageGS110In Commercial Distribution
05010058084650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05010058184657050100581846575010058184657
05010058084650050100580846505010058084650

GMDN Terms

TermDefinition
Tooth extraction forcepsA hand-held manual dental surgical instrument shaped like pincers and designed for the extraction of teeth. This is a reusable device.

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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