FDA.reportPublic FDA data

DANmed

Primary DI
04251351163968
Brand
DANmed
Company
DANNORITZER Medizintechnik GmbH & Co. KG
Model
K5905B
Catalog number
K5905B
Device description
"KERRISON Rongeur, detachable 90°, 5mm, 200mm - 8"""
Published
2020-03-24
Public version status
Update
Distribution status
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
04251351163968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251351163968042513511639684251351163968

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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