FDA.reportPublic FDA data

NA

Primary DI
04058749022544
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
EOI-8
Catalog number
EOI-8
Device description
CERAMO SUPERPLAST spatula 10 x 180 mm, strong pattern
Published
2023-01-20
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
GAFSpatula, Surgical, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAFSpatula, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058749022544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749022544040587490225444058749022544

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. 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
Premarket exempt
true
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06954454000540COTISENHuanghua Promisee Dental Co., Ltd.GAF2026-10-24
06954454000557COTISENHuanghua Promisee Dental Co., Ltd.GAF2026-10-24
06954454001332COTISENHuanghua Promisee Dental Co., Ltd.GAF2026-10-24
04058749022780NAFehling Instruments GmbH & Co. KGGAF2026-10-12
B382SD915039160Surgical DirectSurgical Direct, Inc.GAF2026-10-08
00850088713770PRINCETONPrinceton Medical Group, Inc.GAF2026-09-22
04054462902675evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902682evonosevonos GmbH & Co. KGGAF2026-08-21
04054462902750evonosevonos GmbH & Co. KGGAF2026-08-21
04054462917495evonosevonos GmbH & Co. KGGAF2026-08-19
04054462901548evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902699evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902705evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902712evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902729evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902736evonosevonos GmbH & Co. KGGAF2026-08-18
04054462902743evonosevonos GmbH & Co. KGGAF2026-08-18
B382SD571001EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571002EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
B382SD571004EV0Surgical DirectSurgical Direct, Inc.GAF2026-08-03
08961104622548Spatula 6mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622555Spatula 8.0 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
08961104622562Spatula 10 mm Single SidedMELPEX BEAUTY INSTRUMENTSGAF2026-05-21
00840343727352GEN2SURGIX MEDICAL LLCGAF2026-04-16
10889950147624Hu-FriedyHU-FRIEDY MFG. CO., LLCGAF2026-02-24
00840018668164Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-02-10
00840018662810Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00840018662827Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCGAF2026-01-29
00810158218420PRINCETONPrinceton Medical Group, Inc.GAF2026-01-07