Swann-Morton Ltd. 5621

GUDID 05063043056217

Blade, scalpel, single use. A component of a surgical instrument (scalpel) that is designed to be attached to the scalpel handle. It is capable of cutting through tissue when moved with downward pressure. This device is disposable.

SWANN-MORTON LIMITED

Manual scalpel blade, single-use
Primary Device ID05063043056217
NIH Device Record Keyc2f21bcf-f50e-426d-b600-cf559dfbae29
Commercial Distribution StatusIn Commercial Distribution
Brand NameSwann-Morton Ltd.
Version Model NumberNo.15C BULK NON STERILE KLEEN BLADE MANAGEMENT SYS
Catalog Number5621
Company DUNS212397483
Company NameSWANN-MORTON LIMITED
Device Count500
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS105033955056216 [Primary]
GS105063043056217 [Unit of Use]

FDA Product Code

GESBlade, Scalpel

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


[05063043056217]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-02-16
Device Publish Date2024-02-08

Devices Manufactured by SWANN-MORTON LIMITED

05063043035014 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used
05063043035038 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used
05063043035052 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used
05063043035069 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used
05063043035076 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used
05063043035083 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used
05063043035106 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used
05063043035113 - Swann Morton Ltd.2024-10-23 A hand held, manual surgical instrument constructed as a one piece handle and scalepl blade (not an exchangeable component) used

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