FDA.report

Mastel Precision Surgical Instruments, Inc.

Primary DI
00642356100746
Brand
Mastel Precision Surgical Instruments, Inc.
Company
Mastel Precision Surgical Instruments, Inc.
Model
10.309.3003-55
Catalog number
10.309.3003-55
Device description
President TTE Std. Trunc. Triple Edge, Nichamin Ext. .550mm Preset
Published
2022-08-17
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

Contact Domains

Product Codes

CodeName
HNNKnife, Ophthalmic

Product Code Classifications

CodeDeviceSpecialtyClass
HNNKnife, OphthalmicOphthalmic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00642356100746PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356100746006423561007466423561007460642356100746

GMDN Terms

TermDefinition
Ophthalmic knife, reusableA hand-held manual ophthalmic surgical instrument designed to make precise incisions in the eye and surrounding tissues during ophthalmic surgery. It is typically designed as a one-piece instrument with a sharp, single-edged cutting blade at the distal tip and a handle at the proximal end. It can have a variety of blade edge shapes, e.g., phaco (blunt or sharp), crescent, straight, and micro-phaco (for micro incision cataract surgery). It is usually made of high-grade stainless steel and some types can employ diamond blades. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
18006578057sales@mastel.com

Regulatory Flags

DUNS number
789897865
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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

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00642356001166SteriBestCP471SCP471S2025-07-10
00642356001173SteriBestCP471S-DK-2 00642356001173 2025-07-10
00642356001180SteriBestCP471S-DK-3CP471S-DK-32025-07-10
00642356001197SteriBestCP471S-DK-4CP471S-DK-42025-07-10
00642356001203SteriBestCP471S-DK-5CP471S-DK-52025-07-10
00642356001210SteriBestCP471S-SBCP471S-SB2025-07-10
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