FDA.reportPublic FDA data

Disposable Pin Applicator

Primary DI
06438394002326
Brand
Disposable Pin Applicator
Company
Bioretec Oy
Model
B-DIP-2000
Catalog number
B-DIP-2000
Device description
Applicator with K-Wire Ø2.0 mm, disposable, for 2.0 mm pins
Published
2026-02-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTYPin, Fixation, Smooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTYPin, Fixation, SmoothOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080879000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080879000ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTMBioretec, Ltd.2008-06-24HTY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E302BDIP20009PreviousHIBCC0
06438394002326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438394002326064383940023266438394002326

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, single-useA collection of various sterile orthopaedic surgical instruments, dressings, and other materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width2Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+358207789500sales@bioretec.com

Regulatory Flags#

DUNS number
368715301
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06438394002708Activa InstrumentB-IP-3201B-IP-32012026-03-23
06438394002678Activa InstrumentB-IP-1501B-IP-15012026-03-23
06438394002685Activa InstrumentB-IP-2001B-IP-20012026-03-23
06438394002692Activa InstrumentB-IP-2701B-IP-27012026-03-23
06438394020382Activa InstrumentB-IP-3201B-IP-32012026-03-23
06438394010956Activa InstrumentB-IP-1502B-IP-15022026-03-23
06438394000018ActivaPin™B-AP-1520B-AP-15202026-02-05
06438394000025ActivaPin™B-AP-1530B-AP-15302026-02-05
06438394000032ActivaPin™B-AP-1540B-AP-15402026-02-05
06438394000049ActivaPin™B-AP-1550B-AP-15502026-02-05
06438394000056ActivaPin™B-AP-1560B-AP-15602026-02-05
06438394000063ActivaPin™B-AP-1570B-AP-15702026-02-05
06438394000070ActivaPin™B-AP-2020B-AP-20202026-02-05
06438394000087ActivaPin™B-AP-2030B-AP-20302026-02-05
06438394000094ActivaPin™B-AP-2040B-AP-20402026-02-05
06438394000100ActivaPin™B-AP-2050B-AP-20502026-02-05
06438394000117ActivaPin™B-AP-2060B-AP-20602026-02-05
06438394000124ActivaPin™B-AP-2070B-AP-20702026-02-05
06438394000155ActivaPin™B-AP-2750B-AP-27502026-02-05
06438394000179ActivaPin™B-AP-2770B-AP-27702026-02-05

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Primary DI, Brand, Company table
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00840536825094PedFlex Flexible Nailing SystemORTHOPEDIATRICS CORP.HTY2026-08-14
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