FDA.reportPublic FDA data

Instrapac

Primary DI
05010058083004
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
8300
Catalog number
8300
Device description
Instrapac Dental Hygienist Scaler - Pattern 204S X 40
Published
2025-06-18
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
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058183001PackageGS140In Commercial Distribution
05010058083004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058183001050100581830015010058183001
05010058083004050100580830045010058083004

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical probe, single-useA slender, rod-like, hand-held manual dental surgical instrument intended to be used to explore, measure and/or perform therapeutic procedures during various types of dental surgical intervention. The distal end may be needle-like, hooked, or blunt; it is made of flexible or rigid metallic and/or synthetic polymer material and it may have scaled markings for measurements. 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 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
G879102177H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102184H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791021850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102185H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102186H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102187H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102191H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102196H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102197H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102211H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102212H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102213H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791024050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102RM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
04963931271214NAYDM CORPORATIONEMN2026-07-09
04963931271221NAYDM CORPORATIONEMN2026-07-09
04963931271238NAYDM CORPORATIONEMN2026-07-09
04963931271245NAYDM CORPORATIONEMN2026-07-09
04963931271252NAYDM CORPORATIONEMN2026-07-09
04963931271269NAYDM CORPORATIONEMN2026-07-09
04963931271276NAYDM CORPORATIONEMN2026-07-09
04963931271283NAYDM CORPORATIONEMN2026-07-09
04963931271290NAYDM CORPORATIONEMN2026-07-09
04963931271306NAYDM CORPORATIONEMN2026-07-09
G149TBSB5010TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5020TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5030TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5040TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5110TBS BASICSACME ENTERPRISE.EMN2026-05-20
G149TBSB5150TBS BASICSACME ENTERPRISE.EMN2026-05-20