FDA.report

PILLING

Primary DI
04026704515028
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004522
Catalog number
214230
Device description
WERTHEIM-CULLEN PEDICLE CLAMP
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KNAINSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Product Code Classifications

CodeDeviceSpecialtyClass
KNAInstrument, Manual, Specialized Obstetric-GynecologicObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704515028Direct MarkingGS10
24026704515022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704515028040267045150284026704515028
2402670451502224026704515022

GMDN Terms

TermDefinition
Fixed-diameter cervical dilator, reusableA rod-like, solid surgical instrument designed to dilate the cervical canal after its insertion through the cervical os. Commonly known as a uterine dilator, it is typically made of metal or plastic material and has a tapered, rounded distal tip. It may have one diameter or two different size diameters, one at each end of the instrument. The device is typically available in a set of graduated sizes that are applied in succession. It is used to allow the passage of a curette or other instruments into the uterus and/or enlarge the uterus prior to surgical intervention by pressing on the inner walls of the uterus. This is a reusable device.

Device Sizes

TypeValueUnit
Length220Millimeter

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
false
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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