FDA.report

Aida® awl bowed

Primary DI
04048844072209
Brand
Aida® awl bowed
Company
implantcast GmbH
Model
80071024
Published
2022-06-13
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
HWJAwl

Product Code Classifications

CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048844072209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048844072209040488440722094048844072209

GMDN Terms

TermDefinition
Bone awl, reusableA spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
324369826
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
false
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

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04048844358617MUTARS®770300852026-03-24
04048844358716MUTARS®770301052026-03-24
04048844358792MUTARS®770301252026-03-24
04048844358839MUTARS®770301352026-03-24
04048844732103n/a800930002026-03-24
04048844738150implaFit®800820252026-03-24
04048844731977implaFit®800920002026-03-20
04048844731984implaFit®800920012026-03-20
04048844731991implaFit®800920022026-03-20
04048844732004implaFit®800920032026-03-20
04048844732028implaFit®800920062026-03-20
04048844732042implaFit®800920072026-03-20
04048844732059implaFit®800920082026-03-20
04048844732066implaFit®800920092026-03-20
04048844732080implaFit®800920112026-03-20
04048844732097implaFit®800920122026-03-20
04048844781101implaFit®800920052026-03-20
04048844693350implaFit®800900002026-03-17
04048844693374implaFit®800900022026-03-17
04048844693381implaFit®800900032026-03-17

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06974940306864endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
06974940306918endophixSuzhou Endophix Co., Ltd.HWJ2026-03-03
00199150066889Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-03-02
00190376709246AMP IIALPHATEC SPINE, INC.HWJ2026-02-18
00860015151322EnFix Instrument Kit - TACTETROUS, INC.HWJ2026-02-11
10886982361288NASynthes GmbHHWJ2026-02-11
00860014213427Awl - Non-CuttingTETROUS, INC.HWJ2026-02-10
00860014213434Cutting Awl - 5.5mmTETROUS, INC.HWJ2026-02-10
00860014213441Cutting Awl - 4.5mmTETROUS, INC.HWJ2026-02-10
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