FDA.report

PILLING

Primary DI
04026704514892
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN004496
Catalog number
213160
Device description
KELLY VULSELLUM SIDE CURVED 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
HDCTENACULUM, UTERINE

Product Code Classifications

CodeDeviceSpecialtyClass
HDCTenaculum, UterineObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04026704514892Direct MarkingGS10
24026704514896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04026704514892040267045148924026704514892
2402670451489624026704514896

GMDN Terms

TermDefinition
Uterine tenaculumA hand-held manual surgical instrument with hooks at the distal end used for grasping and/or manipulating uterine tissue during a surgical intervention or examination of the uterus and associated structures (e.g., cervix). It typically has a scissors-like, self-retaining design with ring handles and is made of high-grade stainless steel. It is available in various sizes. This is a reusable device.

Device Sizes

TypeValueUnit
Length252Millimeter

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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GYNX32250Angle HookGYNEX CORPORATIONHDC2016-10-10
GYNX322702-Prong HookGYNEX CORPORATIONHDC2016-10-10
GYNX322903-Prong HookGYNEX CORPORATIONHDC2016-10-10
GYNX32300LLETZ Iris HookGYNEX CORPORATIONHDC2016-10-10
GYNX32400LLETZ Emmett TenaculumGYNEX CORPORATIONHDC2016-10-10
GYNX32450LLETZ Angle HookGYNEX CORPORATIONHDC2016-10-10
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