FDA.reportPublic FDA data

Activa Instrument

Primary DI
06438394020382
Brand
Activa Instrument
Company
Bioretec Oy
Model
B-IP-3201
Catalog number
B-IP-3201
Device description
K-Wire Ø3.2 mm, length 130 mm, for 3.2 mm pins/nails, 10 pcs.
Published
2026-03-23
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06438394002708PrimaryGS10
06438394020382Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06438394002708064383940027086438394002708
06438394020382064383940203826438394020382

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length130Millimeter
Width3.2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
368715301
Device count
10
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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
06438394000216ActivaPin™B-AP-3270B-AP-32702026-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10080196320899MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321407MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321414MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321438MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321452MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321469MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321476MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321483MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321490MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10888277689183MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-25
10080196321445MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-24
00190776431587MillenniumAvalign Technologies, Inc.MDM2026-09-22
00850088713886PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00850088713893PRINCETONPrinceton Medical Group, Inc.MDM2026-09-22
00888867574489Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574496Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574502Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574519Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574526Arthrex®ARTHREX, INC.MDM2026-09-18
00888867574533Arthrex®ARTHREX, INC.MDM2026-09-18
10888277688896MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18
10888277688902MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-18