FDA.reportPublic FDA data

SCHWERT

Primary DI
E8965000280
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
5000-28
Catalog number
5000-28
Device description
"Distal cutter Mini long, 14cm with hard steel inserts max 0,56x0,7mm/0,022x0,028"""
Published
2025-04-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HXZCUTTER, WIRE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXZCutter, WireOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E8965000280PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Wire holding/twisting pliersA heavy-duty manual surgical instrument with specially-designed sturdy handles and blade jaws used to grip, tighten, and/or twist wires during a surgical intervention. It has a scissors-like design with curved handles and is made of high-grade stainless steel. It is available in various sizes and the jaws (typically short and broad with serrations) at the working end are activated through a single pivot or a double ratio-lever exchange pivot to provide greater gripping force. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49746498910700contact@schwert.com

Regulatory Flags#

DUNS number
341195628
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
E8961411020SCHWERT1411-021411-022026-05-21
E8961411050SCHWERT1411-051411-052026-05-21
E896143650SCHWERT1436-51436-52026-04-16
E8961125400B0SCHWERT1125-400B1125-400B2026-03-18
E89628870SCHWERT288728872025-12-16
E8961490500SCHWERT1490-501490-502025-11-27
E8961145610SCHWERT11456-111456-12025-10-15
E89616970207E0SCHWERT1697-02-07E1697-02-07E2025-10-14
E89616970307E0SCHWERT1697-03-07E1697-03-07E2025-10-14
E89616970TI07E0SCHWERT1697-0TI-07E1697-0TI-07E2025-10-14
E8961705207E0SCHWERT1705-2-07E1705-2-07E2025-10-14
E8961705307E0SCHWERT1705-3-07E1705-3-07E2025-10-14
E8961705607E0SCHWERT1705-6-07E1705-6-07E2025-10-14
E89617057507E0SCHWERT1705-75-07E1705-75-07E2025-10-14
E896193950SCHWERT19395193952025-10-14
E89617059007E0SCHWERT1705-90-07E1705-90-07E2025-09-04
E89617059101E0SCHWERT1705-91-01E1705-91-01E2025-09-04
E89617059206E0SCHWERT1705-92-06E1705-92-06E2025-09-04
E89617059303E0SCHWERT1705-93-03E1705-93-03E2025-09-04
E896169701TI07E0SCHWERT1697-01TI-07E1697-01TI-07E2025-07-16

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Primary DI, Brand, Company table
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08800089423880Surgical InstrumentJeil Medical CorporationHXZ2026-04-09
00810118108051NuSmile Hard Wire CutterNUSMILE, LTD.HXZ2026-04-08
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00841506142364GeminusSKELETAL DYNAMICS L.L.C.HXZ2026-01-21
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