FDA.report

MR PHACO

Primary DI
G412PH2205
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH2205
Device description
Meibomian Gland Compressor, Angled, Three Hole Flat Handle, 102mm Overall Length, Stainless Steel
Published
2025-05-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HNRForceps, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNRForceps, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G412PH2205PrimaryHIBCC0

GMDN Terms

TermDefinition
Ophthalmic surgical device handling forceps, reusableA hand-held manual surgical instrument with blades designed to grasp and manipulate a nonimplantable invasive ophthalmic surgical device (e.g., ophthalmic cannula, handless iris retractor) and/or for ophthalmic suturing. It has a tweezers-like design (may be a micro/fine instrument) with two blades joined at the proximal (non-working) end which have variously designed tips at the working end, typically with a slot/groove to accept the ophthalmic device; it is made of metal and is available in various sizes. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
836285668
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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G412PH22060MR PHACOPH22062025-06-09
G412PH22180MR PHACOPH22182025-06-09
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G412PH22780MR PHACOPH22782025-06-09
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G412PH94030MR PHACOPH94032025-06-09
G412PH94071T0MR PHACOPH94071T2025-06-09
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G412PH95400MR PHACOPH95402025-06-09
G412PH98270MR PHACOPH98272025-06-09

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