FDA.reportPublic FDA data

STRADIS HEALTHCARE

Primary DI
M752ZZ06960
Brand
STRADIS HEALTHCARE
Company
STRADIS MEDICAL, LLC
Model
ZZ-0696
Device description
HEMOSTAT, KELLY STRAIGHT
Published
2022-04-29
Public version status
Update
Distribution status
Not 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
HNFScissors, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNFScissors, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M752ZZ06961PackageHIBCC25Not in Commercial Distribution
M752ZZ06960PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
770-962-2425SALES@STRADISHEALTHCARE.COM

Regulatory Flags#

DUNS number
174262477
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M7525251811STRADIS525-1812017-04-01
M75257032650STRADIS HEALTHCARE570-32652023-01-17
M752682026NLXXXXX9STRADIS682-026NL2025-12-31
M7521697700Stradis Medical, LLC.1697702018-03-22
M752ACC25001Stradis Medical, LLC.ACC-25002018-01-29
M752ACC2500N1Stradis Medical, LLC.ACC-2500N2018-04-13
M752ACC25501Stradis Medical, LLC.ACC-25502018-01-29
M752DC1790911Stradis Medical, LLC.DC-17909-12018-05-22
M752DC51601Stradis Medical, LLC.DC-51602018-05-22
M752HCT6625TC0Stradis Medical, LLC.HCT6625TC2017-12-12
M752IM12350Stradis Medical, LLC.IM12352017-12-15
M752IM12510Stradis Medical, LLC.IM12512017-12-15
M752IM12600Stradis Medical, LLC.IM12602019-04-17
M752IMSEN101A0Stradis Medical, LLC.IM-SEN-101A2017-12-14
M752MAG30001Stradis Medical, LLC.MAG-30002018-05-30
M752ACC2550N1Stradis Medical, LLC.ACC-2550N2018-03-27
M752DC850A0Stradis Medical, LLC.DC-850A2018-04-23
M752HCT200BP0Stradis Medical, LLC.HCT200BP2017-12-07
M752HCT6057CP0Stradis Medical, LLC.HCT6057CP2017-12-12
M752HCT6186CP0Stradis Medical, LLCHCT6186CP2017-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04059453161574Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2026-06-03
04251047920554Vannas Capsulotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047921278Metzenbaum ScissorsA1 Medical GmbHHNF2026-05-29
04251047931680Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047931697Super-Cut Westcott Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047932021Super-Cut Stevens Tenotomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936395Vitrectomy ScissorsA1 Medical GmbHHNF2026-05-29
04251047936432Gerten Iridectomy ScissorA1 Medical GmbHHNF2026-05-29
G346EA4018GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2026-04-23
G2231349550Ophthalmic ScissorsMedetz Surgical Instruments LLCHNF2026-04-09
09348811004192INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
09348811004260INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-11-19
G346EA40SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-10-29
G346EA0823GSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHNF2025-09-29
07612717071643FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071704FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
07612717071735FINESSE REFLEXAlcon Laboratories, Inc.HNF2024-06-27
08052276028358Retinal Tip 23G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028372Retinal Tip 25G Microscissors CurvedAKTIVE SRLHNF2024-01-15
08052276028464Retinal Tip vertical 20GAKTIVE SRLHNF2024-01-15
08052276028488Retinal Tip vertical 23GAKTIVE SRLHNF2024-01-15
08052276028501Retinal Tip vertical 25GAKTIVE SRLHNF2024-01-15
0805227602804455° Rotary microscissor 20G only Tip AKTIVE SRLHNF2024-01-11
08052276028129Retinal Tip 20G Microscissors CurvedAKTIVE SRLHNF2024-01-11
08052276028143Retinal Tip 20G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028310Retinal Tip 23G Microscissors StraightAKTIVE SRLHNF2024-01-11
08052276028334Retinal Tip 25G Microscissors StraightAKTIVE SRLHNF2024-01-11
08175700144605Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700144612Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10
08175700145206Corneal ScissorsAURORA SURGICAL, LLCHNF2024-01-10