FDA.reportPublic FDA data

Instrapac

Primary DI
05010058178113
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
7811
Catalog number
7811
Device description
Instrapac Spoon Excavator Large X 40
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
EKCExcavator, Dental, Operative

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058178113PackageGS140In Commercial Distribution
05010058078116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058178113050100581781135010058178113
05010058078116050100580781165010058078116

GMDN Terms#

Term, Definition table
TermDefinition
Dental excavator, single-useA sterile, hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a single-use device.

Storage And Handling#

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