FDA.report

SCHWERT

Primary DI
E896136710
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
13671
Catalog number
13671
Device description
Haemostat. forc. cvd. ADSON
Published
2023-02-23
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
EMDHEMOSTAT, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
EMDHemostat, SurgicalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E896136710PrimaryHIBCC0

GMDN Terms

TermDefinition
Clamp manipulation forcepsA hand-held manual surgical instrument with a dedicated, slotted, working end that is designed to accept, grasp, open, apply and remove small types of bulldog/vascular clamps. It is typically made of high-grade stainless steel with jaws at the working end designed to accept the clamp; this gives the surgeon greater range of use of the bulldog clamp into the wound. It has typically a straight design with a slightly curved geometry toward the working end. 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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00840343726287GEN2SURGIX MEDICAL LLCEMD2025-06-09
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