FDA.report

Pilling

Primary DI
04026704450886
Brand
Pilling
Company
TELEFLEX INCORPORATED
Model
IPN005113
Catalog number
341310
Device description
HEITMILLER MINI THORACOTOMY RETRACTOR
Published
2018-09-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704450886Direct MarkingGS10
24026704450880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704450886040267044508864026704450886
2402670445088024026704450880

GMDN Terms

TermDefinition
Thoracic retractor, self-retainingA self-locking, multi-pivoted, surgical instrument used for drawing aside the margins of a thoracic incision to permit examination or surgical intervention within the thoracic cavity. It will typically have two interchangeable, pivoted, broad and curved blades (self-adjusting their angle as the instrument is opened) at the distal end and a screw mechanism at the proximal end that, when rotated, forces the two legs of the instrument apart, also maintaining its set position once it has been set. It is made of high-grade stainless steel and comes in various designs and sizes for adult and paediatric patients. This is a reusable device.

Device Sizes

TypeValueUnit
Length6.46Inch
Width3.25Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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