FDA.report

NA

Primary DI
04042409353277
Brand
NA
Company
aap Implantate AG
Model
IU 7973-00
Device description
External alignment device
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
04042409353277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042409353277040424093532774042409353277

GMDN Terms

TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

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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