FDA.reportPublic FDA data

NA

Primary DI
04058749061871
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
NNL-7X
Catalog number
NNL-7X
Device description
CERAMO TRADITION X punch 40° upw., 3.0x180mm
Published
2024-04-09
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
04058749061871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749061871040587490618714058749061871

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
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
04058749078008NANVG-1VNVG-1V2026-07-17
04058749078794NANVO-4NVO-42026-07-17
04058749117387NAKOU-8SKOU-8S2026-07-17
04058749121131NATPA-1TPA-12026-07-17
04058749121148NATPA-3TPA-32026-07-17
04058749122671NACOS-4TCOS-4T2026-07-17
04058749122725NACOV-4TCOV-4T2026-07-17
04058749122794NACOX-4TCOX-4T2026-07-17
04058749125917NACOD-6TCOD-6T2026-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776400323MillenniumAvalign Technologies, Inc.HAE2026-07-17
00190776400354MillenniumAvalign Technologies, Inc.HAE2026-07-17
00810220800478Adler Instrument CompanyAdler, Inc.HAE2026-07-17
00190776397128MillenniumAvalign Technologies, Inc.HAE2026-07-16
00190776395520MillenniumAvalign Technologies, Inc.HAE2026-07-14
04255968300020VitalitecVitalitec International Medizintechnik GmbHHAE2026-06-23
07613327651676mild Device KitSTRYKER CORPORATIONHAE2024-11-22
B235MDK00020mild Device KitSTRYKER CORPORATIONHAE2024-06-19
G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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10381780136552Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHAE2016-08-14