FDA.reportPublic FDA data

FMsealer

Primary DI
20859729006169
Brand
FMsealer
Company
DOMAIN SURGICAL, INC.
Model
4001
Catalog number
FM4001
Device description
FMsealer Laparoscopic Shears - 5 mm Diameter / 36 cm Length
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142229000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142229000Laparoscopic FMsealerDomain Surgical, Inc.2015-01-02GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859729006162PackageGS11In Commercial Distribution
20859729006169PackageGS15In Commercial Distribution
00859729006165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085972900616210859729006162
2085972900616920859729006169
00859729006165008597290061658597290061650859729006165

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
963249342
Device count
1
DM exempt
false
Premarket exempt
false
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859729006059FMwand2101FM21012016-06-08
00859729006066FMwand2102FM21022016-06-09
00859729006073FMwand2121FM21212016-06-10
00859729006080FMwand2301FM23012016-06-09
00859729006097FMwand2302FM23022016-06-09
00859729006103FMwand2101SFM2101S2016-06-10
00859729006110FMwand2102SFM2102S2016-06-10
00859729006127FMwand2121SFM2121S2016-06-10
00859729006134FMwand2301SFM2301S2016-06-10
00859729006141FMwand2302SFM2302S2016-06-10
00859729006158FMsealer3001FM30012016-06-15
00859729006165FMsealer4001FM40012016-09-22
00859729006172FMwand2321SFM2321S2016-09-22
00859729006004FMXG1FMG12016-06-08
00859729006011FMXDPMFMDPM2016-06-08
00859729006028FMXRPMFMRPM2016-06-08
00859729006035FMXG1FPFMG1FP2016-06-08
20859729006053FMwand2101FM21012016-06-08
20859729006060FMwand2102FM21022016-06-09
20859729006077FMwand2121FM21212016-06-10

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