FDA.reportPublic FDA data

NeoDevices, Inc.

Primary DI
10816340021066
Brand
NeoDevices, Inc.
Company
NEODEVICES INC
Model
NDF2C
Device description
Curved Graefe forceps
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRNUnit, Cryophthalmic, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRNUnit, Cryophthalmic, Ac-PoweredOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816340027891PackageGS110In Commercial Distribution
10816340021066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081634002789110816340027891
1081634002106610816340021066

GMDN Terms#

Term, Definition table
TermDefinition
Utility forceps, reusableA hand-held manual surgical instrument used for general-purpose grasping/picking up of other devices/objects typically with the intention of maintaining a sterile condition or avoiding direct hand contact because of unhygienic/unfavourable conditions. It typically has a scissors-like design with ring handles and is made of high-grade stainless steel. It is available in various sizes and the working end will typically have grasping blades that are elongated or shaped as large oval or triangular rings. The blades are usually serrated to enhance grip on the objects being picked up. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
866-636-6285info@neodevices.com

Regulatory Flags#

DUNS number
189670230
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816340021632EL-SPIKE-MEL-SPIKE-M2026-06-01
00816340021649EL-SPIKE-FEL-SPIKE-F2026-06-01
00816340021656EL-S55-HFEL-S55-HF2026-06-01
00816340023162Transfer StrawND-S552026-02-05
10816340023145Marian MedicalETT-A-15502025-03-28
10816340021523NeoDevices, Inc.ND60-EL2016-09-24
10816340028355NeoDevices, Inc.ND60-EL2016-09-24
00816340023131SS-1660.13SS-1660.132024-04-17
10816340021097NeoDevices, Inc.LN22102016-09-24
10816340021103NeoDevices, Inc.LN22152016-09-24
10816340027921NeoDevices, Inc.LN22102016-09-24
10816340027938NeoDevices, Inc.LN22152016-09-24
10816340022117NeoDevices, Inc.ND-BF202016-09-24
10816340027808NeoDevices, Inc.ND-BF202016-09-24
00816340023124CT KITCT KIT2023-02-09
10816340023121CT KITCT KIT2023-02-09
10816340023008NeoDevices, Inc.ND-S3EL2016-09-24
10816340023015NeoDevices, Inc.ND-S5EL2016-09-24
10816340023022NeoDevices, Inc.ND-S10EL2016-09-24
10816340023039NeoDevices, Inc.ND-S20EL2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055272707503ADAPTOR FOR F SIZE CO2 CYLINDERKEELER LIMITEDHRN2025-03-26
05055272707527ADAPTOR FOR F SIZE N2O CYLINDERKEELER LIMITEDHRN2025-03-26
05055272721424DORC CRYOSTAR ADAPTORKEELER LIMITEDHRN2025-03-26
05055272721431ERBE ERBOKRYO ADAPTORKEELER LIMITEDHRN2025-03-26
05055272720113Single Use Retinal Cryo Probe (Box of 10 Probes)KEELER LIMITEDHRN2020-11-09
B564MVCY1000PHAKOSPHAKOSHRN2018-10-22
B564MVAD930PHAKOSPHAKOSHRN2018-10-03
B564MVAD94NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD95NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD96NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD97NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD98NG0PHAKOSPHAKOSHRN2018-10-03
B564MVAD99NG0PHAKOSPHAKOSHRN2018-10-03
08717872021416Cryo Probe: Extended Retinal, 2.5mmD.O.R.C. Dutch Ophthalmic Research Center (International) B.V.HRN2017-07-12
05055272707640Cryomatic 2.5mm Std Ret PencilKEELER LIMITEDHRN2016-08-16
050552727076572.5mm Extended Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727076642.5mm Mid-Reach Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727076710.89mm Intra-Vitreal PencilKEELER LIMITEDHRN2016-08-16
050552727076881.5mm Curved Cataract PencilKEELER LIMITEDHRN2016-08-16
050552727076953mm Glaucoma PencilKEELER LIMITEDHRN2016-08-16
050552727077014x10mm Collins Trichiasis PencilKEELER LIMITEDHRN2016-08-16
05055272711753Cryomatic MkII ConsoleKEELER LIMITEDHRN2016-08-16
05055272711760Cryomatic MkII Standard Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727118142.5mm Extended Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727118212.5mm Mid-Reach Retinal PencilKEELER LIMITEDHRN2016-08-16
050552727118380.89mm Intra Vitreal ProbeKEELER LIMITEDHRN2016-08-16
050552727118451.5mm Curved Cataract ProbeKEELER LIMITEDHRN2016-08-16
050552727118523mm Glaucoma ProbeKEELER LIMITEDHRN2016-08-16
050552727118694x10mm Collins Trichiasis PencilKEELER LIMITEDHRN2016-08-16
05055272716963Disposable Cryo Probes, Box of 10KEELER LIMITEDHRN2016-08-16