FDA.report

PILLING

Primary DI
24026704514865
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004492
Catalog number
213150
Device description
HENROTIN VULSELLUM 8 1/4"
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
HTDFORCEPS
KNAINSTRUMENT, MANUAL, SPECIALIZED OBSTETRIC-GYNECOLOGIC

Product Code Classifications

CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1
KNAInstrument, Manual, Specialized Obstetric-GynecologicObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704514861Direct MarkingGS10
24026704514865PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704514861040267045148614026704514861
2402670451486524026704514865

GMDN Terms

TermDefinition
Vaginal speculum, reusableA hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Length210Millimeter

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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