FDA.report

PILLING

Primary DI
54026704801409
Brand
PILLING
Company
TELEFLEX INCORPORATED
Model
IPN020486
Catalog number
P25015
Device description
NH CASTRO DEL CVD W/LOCK JAWS 10MM
Published
2022-12-08
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
HNMNeedle, ophthalmic suturing

Product Code Classifications

CodeDeviceSpecialtyClass
HNMNeedle, Ophthalmic SuturingOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
54026704801409Direct MarkingGS10
14026704801401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
5402670480140954026704801409
1402670480140114026704801401

GMDN Terms

TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusableA hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.

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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