FDA.reportPublic FDA data

NA

Primary DI
04058749079494
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
NVZ-8S
Catalog number
NVZ-8S
Device description
CERAMO bayonet punch w.eject. fl.foot, 4,0x140mm 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
04058749079494PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749079494040587490794944058749079494

GMDN Terms#

Term, Definition table
TermDefinition
Bone-coring punch, reusableA hand-held manual surgical instrument designed to cut out (core) sections of bone, or a combination of bone and soft-tissue, during surgery. It consists of a handle and a cylindrical distal tip which has a bevelled, sharp cutting edge, which when cored into the bone and gently rotated will penetrate and cut through the bone allowing that section to be removed. 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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432331MillenniumAvalign Technologies, Inc.HAE2026-09-24
04250325493537VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301713VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301720VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301737VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301744VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301751VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301836VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301843VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301850VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301867VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301874VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301959VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301966VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301973VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301980VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301997VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302079VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302086VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302109VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302116VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302123VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302130VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302147VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302154VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302161VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302178VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302185VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302192VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302260VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22