FDA.reportPublic FDA data

55° Rotary microscissor 20G only Tip

Primary DI
08052276000347
Brand
55° Rotary microscissor 20G only Tip
Company
AKTIVE SRL
Model
AK-1651(S)
Catalog number
AK-1651(S)
Device description
55° Rotary microscissor 20G only Tip
Published
2024-01-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
08052276028044PrimaryGS10
08052276000347Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052276028044080522760280448052276028044
08052276000347080522760003478052276000347

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic soft-tissue surgical forceps probe-tip, single-useA sterile distal component of a probe-like ophthalmic soft-tissue surgical forceps assembly designed to grasp and manipulate intraocular tissues during ophthalmic surgery (e.g., anterior segment surgery, vitreo-retinal procedures, iridectomy, capsulorhexis). It is a probe-/cannula-like shaft with small grasping blades that protrude from the end of the shaft, and is intended to be attached to an appropriate ophthalmic surgical instrument handle (not included). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
433533053
Device count
5
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08056477557655Phaco Slit Knife 2.4 mm Bevel Up Angled F-24/AF-24/A2024-01-17
08058340226217Phaco Slit Knife 2.4 mm Bevel Up Angled with protectionF-24/AP1F-24/AP12024-01-17
08052276001665Phaco Slit Knife 2.4 mm Dual Bevel Up Angled with protectionF-24/AP2F-24/AP22024-01-17
08056477557662Phaco Slit Knife 2.65 mm Bevel Up Angled F-26/AF-26/A2024-01-17
08058340226224Phaco Slit Knife 2.65 mm Bevel Up Angled with protectionF-26/AP1F-26/AP12024-01-17
08052276015167Phaco Slit Knife 2.65 mm Dual Bevel Angled with protectionF-26/AP2F-26/AP22024-01-17
08056477557679Phaco Slit Knife 2.75 mm Bevel Up AngledF-27/AF-27/A2024-01-17
08058340226248Phaco Slit Knife 2.75 mm Bevel Up Angled with protectionF-27/AP1F-27/AP12024-01-17
08052276015174Phaco Slit Knife 2.75 mm Dual Bevel Angled with protectionF-27/AP2F-27/AP22024-01-17
08056477557686Phaco Slit Knife 2.85 mm Bevel Up Angled F-28/AF-28/A2024-01-17
08058340226279Phaco Slit Knife 2.85 mm Bevel Up Angled with protectionF-28/AP1F-28/AP12024-01-17
08052276015181Phaco Slit Knife 2.8 mm Dual Bevel Angled with protectionF-28/AP2F-28/AP22024-01-17
08056477557693Phaco Slit Knife 3.0 mm Bevel Up AngledF-30/AF-30/A2024-01-17
08058340226286Phaco Slit Knife 3.0 mm Bevel Up Angled with protectionF-30/AP1F-30/AP12024-01-17
08052276015198Phaco Slit Knife 3.0 mm Dual Bevel Angled with protectionF-30/AP2F-30/AP22024-01-17
08056477557709Phaco Slit Knife 3.2 mm Bevel Up Angled F-32/AF-32/A2024-01-17
08058340226293Phaco Slit Knife 3.2 mm Bevel Up Angled with protectionF-32/AP1F-32/AP12024-01-17
08052276015204Phaco Slit Knife 3.2 mm Dual Bevel Angled with protectionF-32/AP2F-32/AP22024-01-17
08052276001689Phaco Slit Knife 3.4 mm Bevel Up Angled with protectionF-34/AP1F-34/AP12024-01-17
08056477557716Scleral Knife Angled G-57/AG-57/A2024-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810220800201Adler Instrument CompanyAdler, Inc.HNF2026-05-26
00192896122833Intraocular SetSONTEC INSTRUMENTS, INC.HNF2026-03-19
00198506089602ELMED INCORPORATEDELMED INCORPORATEDHNF2026-03-17
00192896122819Reynolds Tenotomy ScissorsSONTEC INSTRUMENTS, INC.HNF2026-03-10
00840319758366Hayden MedicalHayden Medical, Inc.HNF2025-12-24
00840319758373Hayden MedicalHayden Medical, Inc.HNF2025-12-24
G2231135500Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
G2231135900Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNF2025-12-16
00852194002045HAI ScissisorsHightech American Industrial Labs IncHNF2025-12-15
04059453156839Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453161697Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
04059453162632Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-12-04
00190776415167MillenniumAvalign Technologies, Inc.HNF2025-12-03
09348811004185INKAThe Trustee for KAISER FAMILY TRUSTHNF2025-12-02
04059453117205Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-09-25
04059453119780Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHNF2025-08-25
00757770406401Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770419197Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770423040Bausch + LombBausch & Lomb IncorporatedHNF2025-08-15
00757770417780Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483563Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770483570Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770486175Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770492350Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00757770510603Bausch + LombBausch & Lomb IncorporatedHNF2025-08-07
00194613003784MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613003791MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004101MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004316MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01
00194613004682MSI Precision Specialty InstrumentsMed Saver, Inc.HNF2025-08-01