FDA.reportPublic FDA data

Impactor Assembly

Primary DI
05060267130785
Brand
Impactor Assembly
Company
XIROS LTD
Model
202-1137
Catalog number
n/a
Published
2017-05-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXJStaple Driver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXJStaple DriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060267130785PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060267130785050602671307855060267130785

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+4401132387202enquiries@neoligaments.com
+441132387202enquiries@xiros.co.uk

Regulatory Flags#

DUNS number
228209805
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060267131812Poly-Tape 30mm x 800mm102-1083n/a2023-07-03
05060267132499Poly-Tape 5 mm x 800 mm 102-1086102-10862022-10-14
05060267132505Poly-Tape 7 mm x 800 mm 102-1087102-10872022-10-14
05060267132512Poly-Tape 10 mm x 800 mm 102-1080102-10802022-10-14
05060267132529Poly-Tape 15 mm x 800 mm 102-1081102-10812022-10-14
05060267132536Poly-Tape 20 mm x 800 mm 102-1082102-10822022-10-14
05060267132543Infinity-Lock 3102-1100102-11002022-10-14
05060267132550Infinity-Lock 5102-1101102-11012022-10-14
05060267132567Infinity-Lock 7 102-1102102-11022022-10-14
05060267131928Infinity-Lock 3102-1100102-11002020-06-04
05060267131935Infinity-Lock 5102-1101102-11012020-06-04
05060267130365Poly-Tape 10 mm x 500 mm102-1010n/a2015-10-09
05060267130372Poly-Tape 15 mm x 500 mm102-1011n/a2015-10-09
05060267130389Poly-Tape 20 mm x 500 mm102-1012n/a2015-10-09
05060267130402Poly-Tape 30 mm x 500 mm102-1013n/a2015-10-09
05060267130433Poly-Tape (dia. 5 mm) x 500 mm (TUBE)102-1040n/a2015-10-09
05060267130471Poly-Tape 10 mm x 800 mm102-1080n/a2015-10-09
05060267130488Poly-Tape 15 mm x 800 mm102-1081n/a2015-10-09
05060267130495Poly-Tape 20 mm x 800 mm102-1082n/a2015-10-09
05060267130501Poly-Tape 30 mm x 800 mm102-1083n/a2015-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03760225718902In2BonesIN2BONESHXJ2024-12-13
05055662969733COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969740COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969757COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969764COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969771COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
05055662969788COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHXJ2024-04-01
06438408004452Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
06438408004520Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
06438408004551Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
06438408004698Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
06438408004704Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
06438408007293Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92819Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92859Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92889Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
M224INS92309Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS92319Inion OTPS Pin InstrumentsInion OyHXJ2020-05-08
M224INS928020Inion FreedomPin InstrumentsInion OyHXJ2020-05-08
10381780051930LARGE UNI-CLIP®NEWDEALHXJ2017-05-31
10381780051947LARGE UNI-CLIP®NEWDEALHXJ2017-05-31
M248119322ND1LARGE UNI-CLIP®NEWDEALHXJ2017-05-31
M248119324ND1LARGE UNI-CLIP®NEWDEALHXJ2017-05-31
00888867002449Arthrex®ARTHREX, INC.HXJ2017-02-15
00888867002456Arthrex®ARTHREX, INC.HXJ2017-02-15
00888867002494Arthrex®ARTHREX, INC.HXJ2017-02-15
00888867002500Arthrex®ARTHREX, INC.HXJ2017-02-15
00888867002548Arthrex®ARTHREX, INC.HXJ2017-02-15
00888867002555Arthrex®ARTHREX, INC.HXJ2017-02-15
00888867002579Arthrex®ARTHREX, INC.HXJ2017-02-15