FDA.reportPublic FDA data

NA

Primary DI
04058749027549
Brand
NA
Company
Fehling Instruments GmbH & Co. KG
Model
KON-5
Catalog number
KON-5
Device description
CERAMO PLANO-S micro needle holder, bayonet, cvd. 1x240 mm
Published
2022-09-16
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
GZXInstrument, Microsurgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZXInstrument, MicrosurgicalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04058749027549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04058749027549040587490275494058749027549

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle holder, reusableA hand-held manual surgical instrument designed to grasp a suture needle when pushing/pulling the needle and attached suture through tissue during suturing. It is typically made of metal and has short serrated jaws at the distal end to provide better grip of the needle. It is available in a wide variety of sizes and designs, such as: 1) a self-retaining, scissors-like design with ring handles at the proximal end; 2) a tweezers-like design with bowed, hinged handles that are operated by squeezing them together; and 3) a heavy-duty pincer-like design. Some types may utilize inserts made of hard materials (e.g., carbide) and include scissor blades. 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159039672SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039689SCANLAN® InstrumentSCANLAN INTERNATIONAL INCGZX2026-05-27
00846159039696SCANLAN® ScissorsSCANLAN INTERNATIONAL INCGZX2026-05-27
04250418753395Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753401Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753418Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753425Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753432Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753449Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-03-27
04250418753296Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753302Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753319Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753326Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753333Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2025-01-02
04250418753258Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753265Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753272Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753289Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-18
04250418753166Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753173Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753180Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753197Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753203Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753210Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753227Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753234Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
04250418753241Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGZX2024-12-17
G223150101200Medetz Surgical InstrumentsMedetz Surgical Instruments LLCGZX2023-06-15
10381780194354Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02
10381780194361Integra® Ruggles®-Redmond™INTEGRA LIFESCIENCES PRODUCTION CORPORATIONGZX2018-04-02