FDA.report

MR PHACO

Primary DI
G412PH61420
Brand
MR PHACO
Company
Crestpoint Management Limited
Model
PH6142
Device description
Carones LASEK Spatula SMALL, The Arc of the spatula represents a 30 Degree section of a 7mm optical zone, Angled 3mm from bend to tip, Round Knurled Handle, 110mm Overall Length, Stainless Steel
Published
2025-06-07
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

Related Records

Product Codes

CodeName
HNDSpatula, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNDSpatula, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G412PH61420PrimaryHIBCC0

GMDN Terms

TermDefinition
General-purpose surgical spatulaA hand-held manual surgical instrument designed to manipulate tissue during various types of surgical interventions. It typically consists of a flat blunt blade (no sharp edges) that is double-ended (a blade at either end) and is not constructed for one particular part of the anatomy or clinical specialty. It is usually made of high-grade stainless steel and is available with a variety of blade designs, e.g., curved and flat or straight and flat with rounded ends; some blade types may be more right-angled. The handle will be formed from its middle section and may be more prominent/serrated. This is a reusable device.

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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G412PH94030MR PHACOPH94032025-06-09
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G412PH95400MR PHACOPH95402025-06-09
G412PH98270MR PHACOPH98272025-06-09

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