FDA.reportPublic FDA data

Instrapac

Primary DI
05010058082694
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8269
Catalog number
8269
Device description
Instrapac Mitchell Trimmer 16.5cm X 10
Published
2025-06-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKCExcavator, Dental, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058182691PackageGS110In Commercial Distribution
05010058082694PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058182691050100581826915010058182691
05010058082694050100580826945010058082694

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, single-useA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length16.5Centimeter

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+441909735502ASKVCI@vernacare.com

Regulatory Flags#

DUNS number
237799775
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
G8791022620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022630DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022640DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022970DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791022980DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027580DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027590DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G8791027600DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-17
G87910217W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910218W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G87910219W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022430DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022440DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022450DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022660DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G8791022670DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX11L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX31W0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX32L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
G879ENX33L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKC2026-08-08
00850083275624Intrace USAPILOTIS TECH LLCEKC2026-07-03
00348783008500Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008517Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008524Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008531Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08
00348783008548Premier ExcavatorsPREMIER DENTAL PRODUCTS COMPANYEKC2026-06-08