FDA.reportPublic FDA data

NA

Primary DI
04058749064179
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
NNU-8S
Catalog number
NNU-8S
Device description
CERAMO bayonet punch with ejector, 4,0x180mm work.length
Published
2023-09-26
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
04058749064179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749064179040587490641794058749064179

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
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
04058749047219NAMSO-3MSO-32026-08-25
04058749007428NABOS-8BOS-82026-07-17
04058749009347NABSF-5BSF-52026-07-17
04058749010060NABSM-8BSM-82026-07-17
04058749045383NAMRQ-0MRQ-02026-07-17
04058749047196NAMSO-1MSO-12026-07-17
04058749047981NAMTE-2MTE-22026-07-17
04058749048131NAMTF-8MTF-82026-07-17
04058749048186NAMTH-0MTH-02026-07-17
04058749049800NANBQ-3NBQ-32026-07-17
04058749058734NANMP-5NMP-52026-07-17
04058749075922NANUM-1NUM-12026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04255968301164VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301171VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301225VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301232VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301249VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301287VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301294VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301300VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301348VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301355VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301362VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301379VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301409VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301416VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301423VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301430VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301478VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301485VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301539VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301546VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301591VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301607VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301652VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
04255968301669VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-18
00190776424008MillenniumAvalign Technologies, Inc.HAE2026-08-27
00190776424084MillenniumAvalign Technologies, Inc.HAE2026-08-27
00850003512006SteribiteSteribite, LLCHAE2026-08-27
00850003512044SteribiteSteribite, LLCHAE2026-08-27
00850003512082SteribiteSteribite, LLCHAE2026-08-27