FDA.reportPublic FDA data

Instrapac

Primary DI
05010058070356
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
7035
Catalog number
7035
Device description
Instrapac Thudicum Nasal Specula Size 6 X 40
Published
2022-08-12
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
EPYSPECULUM, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EPYSpeculum, EntGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058170353PackageGS140In Commercial Distribution
05010058070356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058170353050100581703535010058170353
05010058070356050100580703565010058070356

GMDN Terms#

Term, Definition table
TermDefinition
Nasal speculum, single-useA hand-held surgical instrument which is inserted into a nostril and manually expanded to open the nostril to a maximum by stretching the tissue around the nasal orifice allowing the doctor or surgeon access for examination or surgery during ear/nose/throat (ENT) intervention. It is made of disposable materials and has two blunt, contoured blades that are operated by the operator applying pressure to the pivoted handles or other mechanism. This is a single-use device.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
+441909735502CustomerService.Worksop@vernagroup.com

Regulatory Flags#

DUNS number
237799775
Device count
1
DM 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
05010058070370Instrapac703770372023-08-08
05010058070424Instrapac704270422023-08-08
05010058070479Instrapac704770472022-08-12
05010058070493Instrapac704970492023-08-08
05010058070530Instrapac705370532022-08-12
05010058070578Instrapac705770572023-08-08
05010058070592Instrapac705970592022-08-12
05010058070615Instrapac706170612023-08-08
05010058070639Instrapac706370632022-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04054462156481evonosevonos GmbH & Co. KGEPY2026-08-26
04054462902286evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902293evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902309evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902316evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902330evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902385evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902408evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902415evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902422evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902439evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902446evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902453evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902460evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902477evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902484evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902491evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902507evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902514evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902521evonosevonos GmbH & Co. KGEPY2026-08-21
04054462902538evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904877evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904884evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904891evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904907evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904914evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904938evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904945evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904952evonosevonos GmbH & Co. KGEPY2026-08-21
04054462904969evonosevonos GmbH & Co. KGEPY2026-08-21