FDA.report

NA

Primary DI
04042409227301
Brand
NA
Company
aap Implantate AG
Model
IU 7030-13-1U
Device description
Drill CS 4.5, ø3.0, L 130, quick coupling, single use
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
true

Related Records

Product Codes

CodeName
HTWBIT, DRILL

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04042409227301PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04042409227301040424092273014042409227301

GMDN Terms

TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use 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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