FDA.reportPublic FDA data

27ga Dunn/Rice ILM Pick, Carbon Fiber Handle, Blunt

Primary DI
00840096215137
Brand
27ga Dunn/Rice ILM Pick, Carbon Fiber Handle, Blunt
Company
KATALYST SURGICAL LLC
Model
VP3500B-27
Device description
27ga Dunn/Rice ILM Pick, Carbon Fiber Handle, Blunt
Published
2023-10-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HNQHook, Ophthalmic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HNQHook, OphthalmicOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840096215137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840096215137008400962151378400962151370840096215137

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
007883297
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
00840096215380Disposable Bipolar Forceps, 8", 1.5mm Straight TipsDNK8-15SDNK8-15S2026-10-08
0081748902541323ga DEX™ Morris ILM ForcepsDVF4033-23DVF4033-232026-10-07
0084009620260127ga DEX™ Yoneda Super Grip ForcepsDVF4036-27DVF4036-272026-10-07
0084009620360823ga DEX™ Yoneda Super Grip ForcepsDVF4036-23DVF4036-232026-10-07
0084009620361525ga DEX™ Yoneda Super Grip ForcepsDVF4036-25DVF4036-252026-10-07
0084009620509125ga DEX Stiff NanoTapered Awh ForcepsDVF4005-25-SDVF4005-25-S2026-10-07
0084009620510725ga DEX Stiff Morris Honey Badger ForcepsDVF4010-25-SDVF4010-25-S2026-10-07
0084009620511425ga DEX Stiff Asymmetrical Tano ForcepsDVF4014-25-SDVF4014-25-S2026-10-07
0084009620512125ga (0.50mm) Dex™ Stiff Serrated Jaw ForcepsDVF4016-25-SDVF4016-25-S2026-10-07
0084009620513825ga DEX Stiff Maculorhexis ForcepsDVF4019-25-SDVF4019-25-S2026-10-07
0084009620514525ga DEX Stiff End Grasper ForcepsDVF4022-25-SDVF4022-25-S2026-10-07
0084009620515225ga DEX Stiff Morris ILM ForcepsDVF4033-25-SDVF4033-25-S2026-10-07
0084009620516925ga DEX™ Stiff Super Grip ForcepsDVF4034-25-SDVF4034-25-S2026-10-07
0084009620518325ga DEX Stiff Curved Horizontal ScissorsDVS5006-25-SDVS5006-25-S2026-10-07
0084009620519025ga DEX Stiff Vertical ScissorsDVS5101-25-SDVS5101-25-S2026-10-07
00840096215335Disposable Bipolar Forceps, 7", 0.5mm Straight TipsDNK7-05SDNK7-05S2026-10-07
00840096215342Disposable Bipolar Forceps, 7", 1.0mm Straight TipsDNK7-10SDNK7-10S2026-10-07
00840096215359Disposable Bipolar Forceps, 7", 1.5mm Straight TipsDNK7-15SDNK7-15S2026-10-07
00840096215366Disposable Bipolar Forceps, 8", 0.5mm Straight TipsDNK8-05SDNK8-05S2026-10-07
00840096215373Disposable Bipolar Forceps, 8", 1.0mm Straight TipsDNK8-10SDNK8-10S2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776434939MillenniumAvalign Technologies, Inc.HNQ2026-10-14
00190776434960MillenniumAvalign Technologies, Inc.HNQ2026-10-14
00190776434076MillenniumAvalign Technologies, Inc.HNQ2026-10-09
00190776436308MillenniumAvalign Technologies, Inc.HNQ2026-10-08
00190776433185MillenniumAvalign Technologies, Inc.HNQ2026-10-01
00190776432768MillenniumAvalign Technologies, Inc.HNQ2026-09-29
03700483630219MORIAMORIA SAHNQ2026-09-25
00190776423940MillenniumAvalign Technologies, Inc.HNQ2026-08-27
00190776419714MillenniumAvalign Technologies, Inc.HNQ2026-08-25
G22314029320Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-08-03
B382S340861340Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
B382S344922000Surgical DirectSurgical Direct, Inc.HNQ2026-07-31
00198506092145ELMED INCORPORATEDELMED INCORPORATEDHNQ2026-07-27
G22312240810Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223140340L0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
G223145830T0Medetz Surgical InstrumentsMedetz Surgical Instruments LLCHNQ2026-07-27
00190776400378MillenniumAvalign Technologies, Inc.HNQ2026-07-17
00190776395728MillenniumAvalign Technologies, Inc.HNQ2026-07-14
13700773729644IRIS RETRACTOR 5 HOOKSFCI S A S FCI 20 22HNQ2026-07-09
00757770451531Bausch + LombBausch & Lomb IncorporatedHNQ2026-06-22
04251047903076Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047903359Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047904745Sinskey II Lens Manipulating HookA1 Medical GmbHHNQ2026-06-09
04251047905346Kuglen Iris Hook and Lens ManipulatorA1 Medical GmbHHNQ2026-06-09
04251047925849Vera Fixation HookA1 Medical GmbHHNQ2026-05-29
00190776421151MillenniumAvalign Technologies, Inc.HNQ2026-05-04
00190776420833MillenniumAvalign Technologies, Inc.HNQ2026-04-30
00757770522750Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00757770636082Bausch + LombBausch & Lomb IncorporatedHNQ2026-04-30
00190776420086MillenniumAvalign Technologies, Inc.HNQ2026-04-16