FDA.reportPublic FDA data

NA

Primary DI
04058749077513
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
NVD-6X
Catalog number
NVD-6X
Device description
CERAMO TRADITION X bayo. punch fl. ft, 3,0x200mm, work.length
Published
2023-08-09
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
04058749077513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749077513040587490775134058749077513

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
04058749001228NAKOV-3KOV-32026-10-23
04058749007039NABON-6BON-62026-10-23
04058749009118NABSA-0BSA-02026-10-23
04058749010299NABSZ-1BSZ-12026-10-23
04058749115321NATOQ-0LTOQ-0L2026-10-23
04058749117509NATOZ-3LTOZ-3L2026-10-23
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776439880MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439897MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776440879MilleniumAvalign Technologies, Inc.HAE2026-11-05
00190776439835MilleniumAvalign Technologies, Inc.HAE2026-10-28
B382SD9228132210Surgical DirectSurgical Direct, Inc.HAE2026-10-20
B382SD9228132220Surgical DirectSurgical Direct, Inc.HAE2026-10-20
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00840217900096Ace MedicalEBNER MEDICAL, LLCHAE2021-03-29
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