FDA.reportPublic FDA data

INSTRUMENT

Primary DI
04047844061299
Brand
INSTRUMENT
Company
SIGNUS Medizintechnik GmbH
Model
Awl straight, Lenke
Catalog number
SN0005-A
Device description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Published
2022-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWJAwl

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWJAwlOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04047844061299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844061299040478440612994047844061299

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04047844130971DIPLOMATGuide wire, round/roundAC01622026-08-14
04047844130988DIPLOMATGuide wire, trocar/roundAC01632026-08-14
04047844066768DIPLOMATGuide wire, trocar/roundAC01262025-05-21
04047844042779DIPLOMATGuide wire obturatorAC0003-22022-06-09
04047844066751DIPLOMATGuide wire, round/roundAC01252022-06-09
04047844129418DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-951202026-07-13
04047844129425DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450252026-07-13
04047844129432DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450302026-07-13
04047844129449DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450352026-07-13
04047844129456DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450402026-07-13
04047844129463DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450452026-07-13
04047844129470DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450502026-07-13
04047844129487DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450552026-07-13
04047844129494DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450602026-07-13
04047844129500DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550252026-07-13
04047844129517DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550302026-07-13
04047844129524DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550352026-07-13
04047844129531DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550402026-07-13
04047844129548DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550452026-07-13
04047844129555DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550502026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169524699Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-09-20
04054896000770AwlSilony Medical GmbHHWJ2026-09-18
04054896000787AwlSilony Medical GmbHHWJ2026-09-18
04054896002927AwlSilony Medical GmbHHWJ2026-09-18
04054896005553AwlSilony Medical GmbHHWJ2026-09-18
04054896005560AwlSilony Medical GmbHHWJ2026-09-18
04054896005577AwlSilony Medical GmbHHWJ2026-09-18
04054896014999AwlSilony Medical GmbHHWJ2026-09-18
04054896015002AwlSilony Medical GmbHHWJ2026-09-18
04054896021669AwlSilony Medical GmbHHWJ2026-09-18
04054896024288AwlSilony Medical GmbHHWJ2026-09-18
04054896024295AwlSilony Medical GmbHHWJ2026-09-18
04054896024301AwlSilony Medical GmbHHWJ2026-09-18
04054896024318AwlSilony Medical GmbHHWJ2026-09-18
04054896032818AwlSilony Medical GmbHHWJ2026-09-18
04054896052595AwlSilony Medical GmbHHWJ2026-09-18
04054896052601AwlSilony Medical GmbHHWJ2026-09-18
04054896056777AwlSilony Medical GmbHHWJ2026-09-18
04054896069289AwlSilony Medical GmbHHWJ2026-09-18
04054896079325AwlSilony Medical GmbHHWJ2026-09-18
04054896079332AwlSilony Medical GmbHHWJ2026-09-18
04054896079349AwlSilony Medical GmbHHWJ2026-09-18
04054896079356AwlSilony Medical GmbHHWJ2026-09-18
04054896079363AwlSilony Medical GmbHHWJ2026-09-18
04054896079370AwlSilony Medical GmbHHWJ2026-09-18
04054896079387AwlSilony Medical GmbHHWJ2026-09-18
04054896079394AwlSilony Medical GmbHHWJ2026-09-18
04054896079578AwlSilony Medical GmbHHWJ2026-09-18
04054896079585AwlSilony Medical GmbHHWJ2026-09-18
00199150076482Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWJ2026-08-03