FDA.report

PILLING

Primary DI
04026704450190
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN003595
Catalog number
165240
Device description
BALFOUR RETRACTOR PEDIATRIC
Published
2018-09-15
Public version status
Update
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
FFORETRACTOR, SELF-RETAINING

Product Code Classifications

CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704450190Direct MarkingGS10
24026704450194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704450190040267044501904026704450190
2402670445019424026704450194

GMDN Terms

TermDefinition
Surgical retractor/retraction system blade, reusableA distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during an open surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle because it is available in a variety of lengths and sizes. It is made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Depth37Millimeter
Device Size Text, specify0
Length140Millimeter
Width110Millimeter

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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B382SD4942020Surgical DirectSurgical Direct, Inc.FFO2026-03-02
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B382SD4942060Surgical DirectSurgical Direct, Inc.FFO2026-03-02
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B382SD4942180Surgical DirectSurgical Direct, Inc.FFO2026-03-02
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