FDA.reportPublic FDA data

Instrapac

Primary DI
05010058179721
Brand
Instrapac
Company
ROBINSON HEALTHCARE LIMITED
Model
7972
Catalog number
7972
Device description
Instrapac Trousseau Bowlby Tracheal Dilating Forceps 14cm X 50
Published
2025-05-21
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
KAEFORCEPS, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05010058179721PackageGS150In Commercial Distribution
05010058079724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05010058179721050100581797215010058179721
05010058079724050100580797245010058079724

GMDN Terms#

Term, Definition table
TermDefinition
Tracheal surgery dilator, single-useA sterile, hand-held, manual surgical instrument intended to be used during surgical intervention of the trachea to dilate tracheal structures/passages, typically during the creation of a tracheostoma and/or for expanding the margins of a tracheostoma to assist in the insertion of a tracheostomy tube. It may be in the form of a slender hollow or solid cylinder or a scissors-like instrument. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Centimeter

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
00724995267926Snowden-PencerSTERIS Deutschland GmbHKAE2026-09-25
00724995271466V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995274955V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275013V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275020V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275037V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275044V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275051V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275068V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995275075V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
00724995330002V. MuellerSTERIS Deutschland GmbHKAE2026-09-25
04046826110932MediconMedicon eG. Chirurgiemechaniker-GenossenschaftKAE2026-09-24
G141550875300Carnegie Surgical LLCCarnegie Surgical LLCKAE2026-09-19
00190776420413MillenniumAvalign Technologies, Inc.KAE2026-08-26
00190776420420MillenniumAvalign Technologies, Inc.KAE2026-08-26
04054462901692evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901708evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901715evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901722evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901739evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901746evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901760evonosevonos GmbH & Co. KGKAE2026-08-21
04054462901807evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903160evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903177evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903184evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903191evonosevonos GmbH & Co. KGKAE2026-08-21
04054462903207evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905591evonosevonos GmbH & Co. KGKAE2026-08-21
04054462905607evonosevonos GmbH & Co. KGKAE2026-08-21