FDA.report

NA

Primary DI
04042409035876
Brand
NA
Company
aap Implantate AG
Model
IP 0105-00
Device description
APS connecting screw long, explantation
Published
2018-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042409035876PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042409035876040424090358764042409035876

GMDN Terms

TermDefinition
Orthopaedic implant-instrument extension adaptor, reusableA connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
328420633
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DIBrandModelCatalogPublished
04042409035807NAIP 0104-002018-02-28
04042409035845NAIP 0104-012018-02-28
04042409220159LOQTEQ®IU 8175-402018-02-28
04042409453663CHBSIC 2501-112025-05-21
04042409453724CHBSIC 2501-312025-05-21
04042409453823CHBSIC 2502-112025-05-21
04042409453861CHBSIC 2502-312025-05-21
04042409453922CHBSIC 2503-112025-05-21
04042409453984CHBSIC 2503-212025-05-21
04042409454042CHBSIC 2503-312025-05-21
04042409454103CHBSIC 2504-112025-05-21
04042409454165CHBSIC 2504-212025-05-21
04042409454226CHBSIC 2504-312025-05-21
04042409042256NAIU 8002-002018-02-28
04042409042270NAIU 8004-002018-02-28
04042409194610NAIU 8170-032018-02-28
04042409194627NAIU 8170-042018-02-28
04042409194641NAIU 8171-032018-02-28
04042409194665NAIU 8171-042018-02-28
04042409194672NAIU 8172-012018-02-28

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