FDA.reportPublic FDA data

PEAK MEDICAL

Primary DI
G4533306290
Brand
PEAK MEDICAL
Company
Peak Medical Distribution Inc.
Model
33-0629
Device description
Stainless Steel, Angled 45° Shank, Tear-drop shape paddle tip with Atraumatic and Blunt edges, round, knurled handle, Overall length 110mm (4.5").
Published
2026-06-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
G4533306290PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
078393632
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
G4533312250PEAK MEDICAL33-12252026-06-08
G453PM1580030BC0PEAK MEDICALPM15800-30BC2026-06-08
G4533312BT0PEAK MEDICAL33-12BT2026-06-03
G4533352797GM8M50PEAK MEDICAL3352-797GM8M52026-05-27
G453332414200PEAK MEDICAL3324-14-202026-05-08
G45313110753150PEAK MEDICAL131-1075-3152026-05-06
G453332321055BC010PEAK MEDICAL33-23-21055BC-012026-05-06
G453BH72800PEAK MEDICALBH7-2802026-03-30
G453230117BCL0PEAK MEDICAL23-0117BC-L2026-03-23
G453230117BCR0PEAK MEDICAL23-0117BC-R2026-03-23
G453CFK1000PEAK MEDICALCFK-1002026-03-23
G453333481030PEAK MEDICAL3324-81032024-04-11
G453FA06160PEAK MEDICALFA0-6162026-03-19
G453AR130PEAK MEDICALAR-132026-03-11
G453PM11812CH1PEAK MEDICALPM11-812-CH2026-03-10
G453PM11815CH0PEAK MEDICALPM11-815-CH2026-03-10
G4532420530BC0PEAK MEDICAL24205-30-BC2026-02-24
G453335200112L0PEAK MEDICAL3352001-12L2026-01-05
G4533352003290PEAK MEDICAL3352003-292026-01-05
G4533353003310PEAK MEDICAL3353003-312026-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G346EP175RSS0Epsilon USAEPSILON EYE CARE PRIVATE LIMITEDHND2026-07-06
00850083275983Intrace USAPILOTIS TECH LLCHND2026-07-03
04251047903571Rowen Phaco Spatula & Bechert Nucleus RotatorA1 Medical GmbHHND2026-06-09
00757770688548Bausch + LombBausch & Lomb IncorporatedHND2026-05-11
00190776420994MillenniumAvalign Technologies, Inc.HND2026-04-30
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