FDA.report

SCHWERT

Primary DI
E8961723160
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
1723-16
Catalog number
1723-16
Device description
Exchange blade for bone scraper, curved
Published
2023-02-21
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

Contact Domains

Product Codes

CodeName
EMLCHISEL, BONE, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMLChisel, Bone, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E8961723160PrimaryHIBCC0

GMDN Terms

TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49746498910700contact@schwert.com

Regulatory Flags

DUNS number
341195628
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
true
Sterilization required before use
true

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E8965000540SCHWERT5000-545000-542025-04-08
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E8961411040SCHWERT1411-041411-042025-04-07
E8961411060SCHWERT1411-061411-062025-04-07
E896169710007E0SCHWERT1697-100-07E1697-100-07E2025-04-07
E89616971TI06E0SCHWERT1697-1TI-06E1697-1TI-06E2025-04-07
E896170512007E0SCHWERT1705-120-07E1705-120-07E2025-04-07

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