FDA.report

WECK

Primary DI
34026704672890
Brand
WECK
Company
TELEFLEX INCORPORATED
Model
IPN914814
Catalog number
528236
Device description
VISISTAT 35W NON-STERILE
Published
2019-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
34026704672890PackageGS1100In Commercial Distribution
34026704631798PreviousGS10
14026704672896PrimaryGS10
24026704672893Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
3402670467289034026704672890
3402670463179834026704631798
1402670467289614026704672896
2402670467289324026704672893

GMDN Terms

TermDefinition
Skin stapler/staple, non-bioabsorbableA sterile hand-held manual, surgical instrument preloaded with non-bioabsorbable skin staples designed to approximate free edges of skin from an incision or wound. This stapler is a manually-powered device designed to mechanically deliver the staples; the staples are made of metal [e.g., stainless steel or titanium (Ti)] and intended to be removed once the wound has sufficiently healed. This is a single-use device.

Device Sizes

TypeValueUnit
Length6.5Inch

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
10
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
true
Sterilization required before use
true

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