FDA.reportPublic FDA data

Rowen Phaco Spatula & Bechert Nucleus Rotator

Primary DI
04251047903571
Brand
Rowen Phaco Spatula & Bechert Nucleus Rotator
Company
A1 Medical GmbH
Model
HS-0260TS
Published
2026-06-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HNDSpatula, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251047903571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251047903571042510479035714251047903571

GMDN Terms#

Term, Definition table
TermDefinition
Ophthalmic surgical probe, reusableA slender, rod-like, hand-held manual surgical instrument intended to be used during an ophthalmic procedure to explore, measure, and/or manipulate ocular tissues (e.g., retraction/manipulation of intraocular structures, lens nucleus splitting, removal of foreign bodies in the eye, LASIK flap lifting); it is neither intended to cut tissue nor hook muscles. It is available with a variety of tip shapes including blunt bulbous, hook and T-shape, and the shaft may be straight or bent; it is made of flexible or rigid metallic and/or synthetic polymer material. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9999999999info@a1-medical.com

Regulatory Flags#

DUNS number
342514232
Device count
1
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251047903076Kuglen Iris Hook and Lens ManipulatorHS-0000TS2026-06-09
04251047903090Rosen Phaco SplitterHS-0010TS2026-06-09
04251047903151Nagahara Phaco-ChopperHS-0040TS2026-06-09
04251047903175Nagahara Phaco-ChopperHS-0050TS2026-06-09
04251047903274Lester IOL-ManipulatorHS-0110TS2026-06-09
04251047903359Sinskey II Lens Manipulating HookHS-0150TS2026-06-09
04251047903632Chang Phaco ChopperHS-0310TS2026-06-09
04251047903755Nagahara Phaco-ChopperHS-03602026-06-09
04251047904745Sinskey II Lens Manipulating HookHS-06902026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorHS-09402026-06-09
04251047906688Hofmann-Thornton Fixation RingHS-16102026-06-09
04251047913549Bechert Nucleus RotatorHS-0630C2026-06-09
04251047924804Sterilizing CaseMIS-02102026-06-09
04251047926389Sterilization Tray with LidMIS-06112026-06-09
04251047928604Drysdale Nucleus ManipulatorHS-0091TS2026-06-09
04251047930386Double-level Sterilization TrayMIS-06152026-06-09
04251047934155Gerten Dilator for the Easy Liquid Bubble DMEKHS-0007TS2026-06-09
04251047935398Gerten Easy Liquid Bubble DMEKHS-0008TS2026-06-09
04251047900174Kratz-Barraquer Wire SpeculumES-00902026-05-29
04251047900655Lieberman Eye SpeculumES-03402026-05-29

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Primary DI, Brand, Company table
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00757770688548Bausch + LombBausch & Lomb IncorporatedHND2026-05-11
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00757770501229Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770505753Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511006Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511020Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511037Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770511075Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770520138Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
00757770522682Bausch + LombBausch & Lomb IncorporatedHND2026-04-30
G346EP02SSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346P1607SS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-23
G346EC34Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-20
G346EP1850Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-02
G346EP44900Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-04-01
00841668144398KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144404KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144428KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144435KatenaKATENA PRODUCTS, INC.HND2026-03-31
00841668144442KatenaKATENA PRODUCTS, INC.HND2026-03-31
05056785303350Double Ended Y and ICL Shaped ManipulatorBLINK MEDICAL LIMITEDHND2026-02-04
05056785303336Connor WandBLINK MEDICAL LIMITEDHND2026-01-26
G346EP203L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP203R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP204L0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
G346EP204R0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2025-11-05
05056785302636Connor Wand - StraightBLINK MEDICAL LIMITEDHND2025-11-05
04058935012939Spatula Phaco KochBausch & Lomb GmbHHND2025-10-26
04058935012953Spatula JohnsonBausch & Lomb GmbHHND2025-10-26
04058935012779Fogla Trifacet SpatulaBausch & Lomb GmbHHND2025-10-24