FDA.reportPublic FDA data

NA

Primary DI
04058749063998
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
NNU-2S
Catalog number
NNU-2S
Device description
CERAMO bayonet punch with ejector, 4.0x110mm work.length
Published
2023-09-21
Public version status
New
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K153243000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153243000Fehling-PunchesFehling Instruments GmbH & Co. KG2016-08-04HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058749063998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749063998040587490639984058749063998

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic joint/limb rongeurA hand-held manual surgical instrument designed to remove bone during an orthopaedic intervention of the limbs/joints; it is not primarily intended for nasal, spinal, or cranial use and is not a dedicated rib rongeur. It is a heavy-duty metallic instrument that has a forceps- or pliers-like design and terminates at the distal end with sharp-edged, scoop-shaped jaws attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the jaws to bite (cut) through the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800 334-5464info@fehlingsurgical.com

Regulatory Flags#

DUNS number
315028238
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04058749009897NABSL-6BSL-62026-10-12
04058749012842NACOF-3COF-32026-10-12
04058749013375NACOM-7COM-72026-10-12
04058749013818NACOT-7COT-72026-10-12
04058749022780NAEOM-1EOM-12026-10-12
04058749027969NAKOU-4HKOU-4H2026-10-12
04058749044249NAMRF-1VMRF-1V2026-10-12
04058749125931NACOC-3TCOC-3T2026-10-12
04058749126471NANOK-8NOK-82026-10-12
04058749012446NACOB-4COB-42026-09-21
04058749037364NAMEJ-2MEJ-22026-09-21
04058749076042NANUN-5NUN-52026-09-21
04058749001280NAMBK-8MBK-82026-09-04
04058749008944NABRX-2BRX-22026-09-04
04058749012521NACOC-2COC-22026-09-04
04058749036350NAMBR-2MBR-22026-09-04
04058749046076NAMRW-4GMRW-4G2026-09-04
04058749122626NACOE-2TCOE-2T2026-09-04
04058749004496NABBO-1BBBO-1B2026-08-25
04058749006032NABOC-6BOC-62026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04255968300433VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968301812VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968301829VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968301935VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968301942VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302055VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302062VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302253VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302338VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302345VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302406VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302413VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302475VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302482VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302543VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302550VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302642VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302659VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302710VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302727VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302758VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302765VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968302772VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-13
04255968301775VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-12
04255968301782VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-12
04255968301799VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-12
04255968301805VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-12
04255968301898VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-12
04255968301904VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-12
04255968301911VitalitecVitalitec International Medizintechnik GmbHHAE2026-10-12