FDA.reportPublic FDA data

Stat Tack

Primary DI
05708932479462
Brand
Stat Tack
Company
Coloplast A/S
Model
501260
Catalog number
501260
Device description
Fixation Device
Published
2016-03-29
Public version status
Update
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
GDWSTAPLE, IMPLANTABLE

Product Code Classifications

CodeDeviceSpecialtyClass
GDWStaple, ImplantableGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05708932479462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05708932479462057089324794625708932479462

GMDN Terms

TermDefinition
Surgical binding material anchor setA collection of devices designed to implant a non-bioabsorbable fixation anchor into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials (e.g., mesh, sutures). The set typically consists of non-bioabsorbable fixation anchors, possibly contained within a cartridge, and a mechanical applicator used to hold, position, and insert each anchor into the target tissue; and possibly a drill or punch to create the hole to deliver the anchor. This is a single-patient device.

Device Sizes

TypeValueUnit
Outer Diameter5Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)258-3476urology@coloplast.com

Regulatory Flags

DUNS number
305524696
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
05708932778268SpeediCath Flex Set28941289412026-02-05
05708932778275SpeediCath Flex Set28942289422026-02-05
05708932778282SpeediCath Flex Set28946289462026-02-05
03600040963876ColoplastAC5904AC59042026-01-30
03600040963944ColoplastAC5905AC59052026-01-30
03600040964026ColoplastAC5906AC59062026-01-30
03600040964095ColoplastAC5907AC59072026-01-30
03600040964170ColoplastAC5908AC59082026-01-30
03600040964231ColoplastAC5909AC59092026-01-30
03600040964293ColoplastAC5910AC59102026-01-30
03600040964361ColoplastAC5911AC59112026-01-30
03600040964415ColoplastAC5912AC59122026-01-30
03600040964651ColoplastAC5C07AC5C072026-01-30
03600040965894ColoplastACP205ACP2052026-01-30
03600040965948ColoplastACP206ACP2062026-01-30
03600040966006ColoplastACP207ACP2072026-01-30
03600040966068ColoplastACP208ACP2082026-01-30
03600040966136ColoplastACP303ACP3032026-01-30
03600040966228ColoplastACP304ACP3042026-01-30
03600040966310ColoplastACP305ACP3052026-01-30

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