FDA.reportPublic FDA data

DANmed

Primary DI
04251351161957
Brand
DANmed
Company
DANNORITZER Medizintechnik GmbH & Co. KG
Model
K5404B-D-S
Catalog number
K5404B-D-S
Device description
"KERRISON Rongeur, detachable, down 40°, 4mm, 200mm - 8"" black ceramic coating"
Published
2020-03-03
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAERONGEUR, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251351161957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251351161957042513511619574251351161957

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497461962390udi@danrepair.de

Regulatory Flags#

DUNS number
314648911
Device count
1
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
04251351162701DANmedK5901A-THINK5901A-THIN2020-03-24
04251351162718DANmedK5901BK5901B2020-03-24
04251351162725DANmedK5901B-DK5901B-D2020-03-24
04251351162763DANmedK5901B-THINK5901B-THIN2020-03-24
04251351162770DANmedK5901CK5901C2020-03-24
04251351162787DANmedK5901C-DK5901C-D2020-03-24
04251351162831DANmedK5901C-THINK5901C-THIN2020-03-24
04251351162848DANmedK5901DK5901D2020-03-24
04251351162855DANmedK5901D-DK5901D-D2020-03-24
04251351162893DANmedK5901D-THINK5901D-THIN2020-03-24
04251351162909DANmedK5902AK5902A2020-03-24
04251351162916DANmedK5902A-DK5902A-D2020-03-24
04251351162954DANmedK5902A-THINK5902A-THIN2020-03-24
04251351162961DANmedK5902AEK5902AE2020-03-24
04251351162985DANmedK5902BK5902B2020-03-24
04251351162992DANmedK5902B-DK5902B-D2020-03-24
04251351163036DANmedK5902B-THINK5902B-THIN2020-03-24
04251351163043DANmedK5902BEK5902BE2020-03-24
04251351163067DANmedK5902CK5902C2020-03-24
04251351163128DANmedK5902CEK5902CE2020-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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