FDA.report

DJO SURGICAL

Primary DI
00190446266129
Brand
DJO SURGICAL
Company
Encore Medical, L.P.
Model
801-05-051
Device description
DJO EMPOWR KNEETM CEMENTED STEMMABLE TIBIAL PUNCH, LARGE
Published
2018-09-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LRYPUNCH, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
LRYPunch, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190446266129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190446266129001904462661291904462661290190446266129

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
154074504
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00190446905998DJO SURGICAL800-05-2142026-03-03
00190446960515DJO SURGICALS-2019612026-02-17
00190446905950DJO SURGICAL800-05-2102026-02-11
00190446905974DJO SURGICAL800-05-2112026-02-11
00190446906087DJO SURGICAL800-99-1672026-02-11
00190446906117DJO SURGICAL801-05-2122026-02-11
00190446924470DJO SURGICALS-2019282025-10-10
00190446946007DJO SURGICALS-2019562025-12-11
00190446893332DJO SURGICAL941-01-32B2025-12-04
00190446893349DJO SURGICAL941-01-36D2025-12-04
00190446893356DJO SURGICAL941-01-40F2025-12-04
00190446893363DJO SURGICAL941-01-44H2025-12-04
00190446893370DJO SURGICAL942-01-32B2025-12-04
00190446893387DJO SURGICAL942-01-36D2025-12-04
00190446893394DJO SURGICAL942-01-40F2025-12-04
00190446893400DJO SURGICAL942-01-44H2025-12-04
00190446893417DJO SURGICAL943-01-32B2025-12-04
00190446893424DJO SURGICAL943-01-36D2025-12-04
00190446893431DJO SURGICAL943-01-40F2025-12-04
00190446893448DJO SURGICAL943-01-44H2025-12-04

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08681506800282SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2026-02-17
08681506800299SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2026-02-17
08681506800268SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-25
08681506800275SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-25
08681506800060SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800077SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800091SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800107SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800114SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800121SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800138SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800145SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800152SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800169SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800176SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800183SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800190SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800206SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800213SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800220SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800237SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800244SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800251SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-09
08681506800015SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800022SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800039SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800046SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800053SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
08681506800084SCHARFSCHARF TOOLS IHRACAT ITHALAT LIMITED SIRKETILRY2025-12-08
04262494460029N/ADoppkon GmbH & Co. KGLRY2025-12-04