FDA.report

WECK

Primary DI
34026704631767
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN028495
Catalog number
525980
Device description
WECKSTAT STAPLE EXTRACTOR 12/BOX
Published
2019-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GDTSTAPLE, REMOVABLE (SKIN)

Product Code Classifications

CodeDeviceSpecialtyClass
GDTStaple, Removable (Skin)General, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704631767PackageGS112In Commercial Distribution
44026704631764PackageGS134In Commercial Distribution
04026704600731PreviousGS10
14026704631763PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670463176734026704631767
4402670463176444026704631764
04026704600731040267046007314026704600731
1402670463176314026704631763

GMDN Terms

TermDefinition
Surgical staple remover, single-useA sterile surgical instrument that is used to remove skin staples after the healing process has progressed sufficiently to permit the borders of the wound or incision to remain together without assistance. It is a tweezers-like device made of high-grade stainless steel with blades at the distal end activated by lever action designed for grasping, opening, and removing surgical staples. This is a single-use device.

Device Sizes

TypeValueUnit
Length5.6Inch

Sterilization Methods

Method

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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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