FDA.reportPublic FDA data

General-purpose ophthalmic hook, reusable

Primary DI
03760087126228
Brand
General-purpose ophthalmic hook, reusable
Company
FCI S A S FCI 20 22
Model
CRAWFORD HOOK
Catalog number
S1.1275
Device description
A hand-held manual surgical instrument intended to facilitate the manipulation of ocular structures or to remove foreign bodies in the eye. It is typically shaft-like with a small curve (blunt- or pointed-end) or bend distally, and a handle proximally. The device is commonly used to retract eye muscles or to stabilize and manoeuver tissue during posterior segment surgery. This is a reusable device.
Published
2020-02-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Contact Domains#

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
03760087126228PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760087126228037600871262283760087126228

GMDN Terms#

Term, Definition table
TermDefinition
Ocular hook/spatula/manipulator, reusableA hand-held, blunt, manual ophthalmic surgical instrument intended for manipulation/retraction of intraocular structures, lens nucleus splitting/manipulation, removal of foreign bodies in the eye, corneal manipulation (e.g., LASIK flap lifting), and/or in situ intraocular lens (IOL) manipulation; it is neither intended to cut tissue nor hook muscles. It may be of single- or double-ended design with a working end(s) designed as a hook, spatula, or other manipulator (often Y-shaped); it is not a curette, loop, trabeculotome, spoon, or inner limiting membrane (ILM) scraper. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length78Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-932-4202orders@fci-ophthalmics.com

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
13700773728111SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602026-02-17
13760087123712SIZERS SET (ENUCLEATION / EVISCERATION) SINGLE USES6.30602021-05-30
23700773707472MACULORHEXIS FORCEPS 27 G S9.6012.272021-05-30
23700773707489END GRASPING FORCEPS 27 G S9.6013.272021-05-30
23700773707496TANO FORCEPS 27 G S9.6017.272021-05-30
23700773707502pince super grip 23GS9.6018.232021-05-30
23700773707519pince super grip 25GS9.6018.252021-05-30
23700773707526pince super grip 27GS9.6018.272021-05-30
23700773721041TANO POLISHER,20G S9.6016.202021-05-29
23700773721058TANO POLISHER,23G S9.6016.232021-05-29
23700773721065TANO POLISHER,25G S9.6016.252021-05-29
23700773721225DISPOSABLE TANO FORCEPS 23GS9.6017.232021-05-30
23700773721232DISPOSABLE TANO FORCEPS 25GS9.6017.252021-05-30
23700773721249DISPOSABLE SERRATED FORCEPS 23GS9.6011.232021-05-30
23700773721256DISPOSABLE SERRATED FORCEPS 25GS9.6011.252021-05-30
23700773721263DISPOSABLE MACULORHEXIS FORCEPS, 23GS9.6012.232021-05-30
23700773721270DISPOSABLE MACULORHEXIS FORCEPS, 25GS9.6012.252021-05-30
23700773721287DISPOSABLE END-GRASPING FORCEPS, 23GS9.6013.232021-05-30
23700773721294DISPOSABLE END-GRASPING FORCEPS, 25GS9.6013.252021-05-30
23700773721324DISPOSABLE VERTICAL SCISSORS, 23GS9.6015.232021-05-30

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Primary DI, Brand, Company table
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