FDA.reportPublic FDA data

MACKOOL™ HOOKS (1X5)

Primary DI
13700773737113
Brand
MACKOOL™ HOOKS (1X5)
Company
FCI S A S FCI 20 22
Model
S8.5151
Published
2026-11-02
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
HOCClip, Iris Retractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HOCClip, Iris RetractorOphthalmic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13700773737113PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1370077373711313700773737113

Regulatory Flags#

DUNS number
763408366
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
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
13700773728067PRELOADED PUNCTAL PLUG (MINI US) - J.A. BERNARDS2.36722026-10-08
03760087120066Lacrimal punctum plugREADY-SET PUNCTUM PLUG (MINI, US 0.7)S2.3672u2020-02-25
13700773729644IRIS RETRACTOR 5 HOOKSS9.50152026-07-09
13700773731906TearSaver® - 0.4 mmS2.38422026-07-09
13700773731913TearSaver® - 0.5 mmS2.38522026-07-09
13700773736994TearSaver® - 0.8 mmS2.38822026-07-09
13700773737007Snug plugS2.4002U2026-07-09
23700773728705PRELOADED PERFORATED PLUG PVP - J.A. BERNARDS1.35122026-07-09
23700773728712PRELOADED MINI PERFORATED PLUG PVP - J.A. BERNARDS1.35222026-07-09
13700773729651STOPLOSS® JONES TUBE 3,5 X 9 MM S1.73092026-04-20
13700773729668STOPLOSS® JONES TUBE 3,5 X 10 MM S1.73102026-04-20
13700773729675STOPLOSS® JONES TUBE 3,5 X 11 MM S1.73112026-04-20
13700773729682STOPLOSS® JONES TUBE 3,5 X 12 MM S1.73122026-04-20
13700773729699STOPLOSS® JONES TUBE 3,5 X 13 MM S1.73132026-04-20
13700773730817STOPLOSS® JONES TUBE INTRODUCER SET S1.75002026-04-20
13700773731920STOPLOSS® JONES TUBE 3,5 X 14 MM S1.73142026-04-20
13700773731937STOPLOSS® JONES TUBE 3,5 X 15 MM S1.73152026-04-20
13700773731968STOPLOSS® JONES TUBE 3,5 X 16 MM S1.73162026-04-20
13700773731975STOPLOSS® JONES TUBE 3,5 X 17 MM S1.73172026-04-20
13700773731982STOPLOSS® JONES TUBE 3,5 X 18 MM S1.73182026-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194613041533MSI Precision Specialty InstrumentsMed Saver, Inc.HOC2025-08-01
00194613103095MSI Precision Specialty InstrumentsMed Saver, Inc.HOC2025-08-01
08052276027054Set of 4 Iris RetractorsAKTIVE SRLHOC2024-01-11
08052276027061Set of 5 Iris RetractorsAKTIVE SRLHOC2024-01-11
08058340220970Set of 4 Iris RetractorsAKTIVE SRLHOC2024-01-11
08056477550502Set of 5 Iris RetractorsAKTIVE SRLHOC2024-01-11
04049368058045N.A.Geuder AktiengesellschaftHOC2023-07-06
04049368058199N.A.Geuder AktiengesellschaftHOC2023-07-06
00845819000458OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
00845819005200Disposable Instruments OASIS MEDICAL, INC.HOC2023-06-30
10845819000455OASIS® Iris ExpanderOASIS MEDICAL, INC.HOC2023-06-30
10845819005207Disposable Instruments OASIS MEDICAL, INC.HOC2023-06-30
00841668143452MAXIRIS FLEXIBLE IRIS RETRACTOR PACK/5KATENA PRODUCTS, INC.HOC2022-12-13
00841668143469MAXIRIS AKAHOSHI FLAT IRIS RETRACT PK/5KATENA PRODUCTS, INC.HOC2022-12-13
00841668143476MAXIRIS AKAHOSHI TW FIBR IRIS/CAP RETRACKATENA PRODUCTS, INC.HOC2022-12-13
00841668127377GRAETHER IRIS RETRACTOR STRAIGHTKATENA PRODUCTS, INC.HOC2022-12-07
00841668127384GRAETHER IRIS RETRACTOR ANGLEDKATENA PRODUCTS, INC.HOC2022-12-07
00841668118887Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00841668118894Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00841668119747Iris RetractorKATENA PRODUCTS, INC.HOC2022-11-16
00813059018403Diamatrix LtdDiamatrixHOC2022-10-31
00813059018397Diamatrix LtdDiamatrixHOC2022-10-31
00840319726105Hayden MedicalHayden Medical, Inc.HOC2022-08-16
30886158007037Visitec®Beaver-Visitec International, Inc.HOC2022-01-26
00886158007036Visitec®Beaver-Visitec International, Inc.HOC2022-01-26
00886158007043Visitec® I-Ring®Beaver-Visitec International, Inc.HOC2022-01-20
00850003089188N/AOptalmed, LLCHOC2021-03-10
00850003089201N/AOptalmed, LLCHOC2021-03-10
10850003089208N/AOptalmed, LLCHOC2021-03-10
00850003089034N/AOptalmed, LLCHOC2021-02-08