FDA.reportPublic FDA data

NA

Primary DI
04058749087659
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
TEJ-1
Catalog number
TEJ-1
Device description
CERAMO CONCEPT CLASSIC punch flat foot, 40° upw. 1.0x400m
Published
2023-12-19
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
04058749087659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749087659040587490876594058749087659

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
04058749006841NABOL-6BOL-62026-04-22
04058749007084NABOO-2BOO-22026-04-22
04058749008586NABRK-4BRK-42026-04-22
04058749009392NABSG-4BSG-42026-04-22
04058749009798NABSK-6BSK-62026-04-22
04058749010091NABSN-1BSN-12026-04-22
04058749025750NAKCA-7KCA-72026-04-22
04058749025774NAKCB-8KCB-82026-04-22
04058749040517NAMME-4MME-42026-04-22
04058749043198NAMPB-3MPB-32026-04-22
04058749043686NAMRB-3MRB-32026-04-22
04058749044669NAMRJ-4MRJ-42026-04-22
04058749044812NAMRK-9PMRK-9P2026-04-22
04058749045963NAMRV-8MRV-82026-04-22
04058749046588NAMSD-5MSD-52026-04-22
04058749049664NANBL-9NBL--2026-04-22
04058749055252NANLA-4NLA-42026-04-22
04058749075977NANUM-6NUM-62026-04-22
04058749076264NANUR-2NUR-22026-04-22
04058749076295NANUR-5NUR-52026-04-22

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G277G2N732330GEN2SURGIX MEDICAL LLCHAE2022-09-28
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