FDA.reportPublic FDA data

Instrapac

Primary DI
05010058184725
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8472
Catalog number
8472
Device description
Instrapac Dental Luxation Instrument 5C (5mm 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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMJElevator, Surgical, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMJElevator, Surgical, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058184725PackageGS110In Commercial Distribution
05010058084728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058184725050100581847255010058184725
05010058084728050100580847285010058084728

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry and keep out of direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05010058070158Instrapac701570152023-08-08
05010058070172Instrapac7017 Delivery Pack - 18cm/7in Forceps70172020-11-26
05010058070219Instrapac702170212022-08-12
05010058070226Instrapac702270222022-08-12
05010058070233Instrapac702370232022-08-12
05010058070240Instrapac702470242023-08-08
05010058070264Instrapac702670262024-02-28
05010058070318Instrapac703170312022-08-12
05010058070325Instrapac703270322022-08-12
05010058070332Instrapac703370332022-08-12
05010058070349Instrapac703470342022-08-12
05010058070356Instrapac703570352022-08-12
05010058070370Instrapac703770372023-08-08
05010058070424Instrapac704270422023-08-08
05010058070479Instrapac704770472022-08-12
05010058070493Instrapac704970492023-08-08
05010058070530Instrapac705370532022-08-12
05010058070578Instrapac705770572023-08-08
05010058070592Instrapac705970592022-08-12
05010058070615Instrapac706170612023-08-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D955BDT11Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT21Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT31Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT61Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT71Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT81Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955BDT91Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE461Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE571Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE581Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
D955ELE77RW1Paul BandittTerlain Enterprises, Inc.EMJ2026-09-25
G879LXB50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-25
G879103420TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034210DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791034220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879106049TIT0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G8791061170DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-14
G879101067S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101067M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068M0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
G879101068S0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMJ2026-08-13
00190776408688MillenniumAvalign Technologies, Inc.EMJ2026-08-03
00190776400224MillenniumAvalign Technologies, Inc.EMJ2026-07-21
00190776403706MillenniumAvalign Technologies, Inc.EMJ2026-07-21
00190776395506MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395513MillenniumAvalign Technologies, Inc.EMJ2026-07-14
00190776395544MillenniumAvalign Technologies, Inc.EMJ2026-07-14