FDA.report

PILLING

Primary DI
24026704515091
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004531
Catalog number
214688
Device description
STAMEY NEEDLE STRAIGHT
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
GDMNEEDLE, ASPIRATION AND INJECTION, REUSABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GDMNeedle, Aspiration And Injection, ReusableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704515097Direct MarkingGS10
24026704515091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704515097040267045150974026704515097
2402670451509124026704515091

GMDN Terms

TermDefinition
Suprapubic needle, surgical, reusableA hand-held manual surgical instrument designed with a sharp pyramidal or conical point at the distal end to percutaneously puncture the lower abdominal wall to provide suprapubic access for surgical repair, typically to position a sling used in the treatment of female stress urinary incontinence (SUI) associated with bladder prolapse. The needle is typically made of a high-grade stainless steel rod (curved or malleable) with a pointed tip and an eye or notch at the distal end to help position the sling. The proximal end can have a handle made of metal or durable plastic. This is a reusable device.

Device Sizes

TypeValueUnit
Length248Millimeter

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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