FDA.reportPublic FDA data

SCHWERT

Primary DI
E89610470
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
1047
Catalog number
1047
Device description
Scalpel handles No. 7
Published
2023-02-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDZHANDLE, SCALPEL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDZHandle, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E89610470PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Scalpel handle, reusableA device that is an interchangeable component of a scalpel and that functions as a handle designed to mount a compatible blade. This device with the blade become a single-bladed surgical instrument intended to be used by a physician for cutting or dissecting tissue. The device is typically made of metal (e.g., stainless steel or brass). 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776396800MillenniumAvalign Technologies, Inc.GDZ2026-07-14
00850083275563Intrace USAPILOTIS TECH LLCGDZ2026-07-03
00810055255689Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255696Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255702Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255726Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255788Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255801Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255825Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055255863Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256105Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256112Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256129Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256136Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256150Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256174Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256181Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256198Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810055256204Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00810189455139Surgical DesignSurgical Design, Inc.GDZ2026-06-26
00190776421847MillenniumAvalign Technologies, Inc.GDZ2026-06-25
00810055257348Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257355Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257362Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257379Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257386Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00810055257850Surgical DesignSurgical Design, Inc.GDZ2026-05-29
00190776421533MillenniumAvalign Technologies, Inc.GDZ2026-05-05
00190776419769MillenniumAvalign Technologies, Inc.GDZ2026-04-15
00190776419776MillenniumAvalign Technologies, Inc.GDZ2026-04-15