FDA.reportPublic FDA data

E.M. Adams Company

Primary DI
10840200325322
Brand
E.M. Adams Company
Company
E.M. ADAMS, INC.
Model
14-3390-1
Device description
SINGLE INSTRUMENT
Published
2022-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K812133000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K812133000WOUND CLOSURE INSTRUMENT TRAYE.M. Adams1982-01-08FSM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30840200325326PackageGS120In Commercial Distribution
50840200325313PackageGS1100In Commercial Distribution
10840200325322PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3084020032532630840200325326
5084020032531350840200325313
1084020032532210840200325322

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, single-useA hand-held manual surgical instrument designed to cut/dissect a variety of tissues during open surgery and having no dedication to a specific anatomy or clinical use; it might in addition be intended for cutting materials associated with surgery (e.g., sutures). It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed; some types may have blades that cross over to expose a sharp edge for slicing tissue like a scalpel. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
(772)-461-0532EMADAMS@EMADAMSCO.COM

Regulatory Flags#

DUNS number
001403807
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10840200300688E.M Adams co, inc.114-31333-12021-05-20
10840200301241E.M Adams co, inc.114-A7006-12021-05-22
10840200302668E.M Adams co, inc.14-60108-12021-05-21
10840200302309E.M Adams co, inc.14-3444-12021-05-21
18100013402309E.M Adams co, inc.14-3444-12019-12-31
10840200325599E.M. Adams Co Inc14-70809JK-12023-11-21
50840200325580E.M. Adams Co Inc14-70809JK-12023-11-21
10840200325575E.M. Adams Co, Inc114-A3609-12023-11-17
50840200325566E.M. Adams Co, Inc114-A3609-12023-11-17
10840200301081E.M. Adams Co Inc114-A11341-12023-10-31
50840200301072E.M. Adams Co Inc114-A11341-12023-10-31
10840200325551E.M. Adams Co Inc114-31613-12023-10-31
10840200325537E.M. Adams Co, Inc.14-3497-12023-10-20
50840200325528E.M. Adams Co, Inc.14-3497-12023-10-20
10840200325452E.M. Adams co, inc.EP30405L-12023-06-20
50840200325443E.M. Adams co, inc.EP30405L-12023-06-20
10840200302040E.M Adams co, inc.14-3358-12021-05-21
10840200302217E.M Adams co, inc.14-3392-12021-05-21
10840200302248E.M Adams co, inc.14-3393-12021-05-21
18100013401999E.M Adams co, inc.14-3350-12019-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995239992V. MuellerSteris CorporationFSM2026-10-15
00724995240004V. MuellerSteris CorporationFSM2026-10-15
00724995240011V. MuellerSteris CorporationFSM2026-10-15
00724995240028V. MuellerSteris CorporationFSM2026-10-15
00724995243401V. MuellerSteris CorporationFSM2026-10-15
00889795150271APEX 3D Total Ankle Replacement SystemParagon 28, Inc.FSM2026-10-12
00190446960386Active AdaptiveMedshape, Inc.FSM2026-10-09
00850045406615clamp-itGeneral Hospital Supply CorpFSM2026-10-01
00190776434588MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776434595MillenniumAvalign Technologies, Inc.FSM2026-09-30
00190776435899MillenniumAvalign Technologies, Inc.FSM2026-09-30
16931918122397AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918176680AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
16931918191614AllesetGRI Medical & Electronic Technology Co., Ltd.FSM2026-09-29
00190376733470CONTOUR3DALPHATEC SPINE, INC.FSM2026-09-25
00889795135278Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135285Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135292Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135308Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135315Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135322Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
00889795135339Baby Gorilla®/Gorilla® Plating SystemParagon 28, Inc.FSM2026-09-24
10889950159221Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-09-24
10888857252820DENALI® Spinal SystemVB Spine LLCFSM2026-08-28
10888857253056DENALI® Spinal SystemVB Spine LLCFSM2025-12-18
10888857291980MESA® Spinal SystemVB Spine LLCFSM2025-12-18
10888857446267MESA® Spinal SystemVB Spine LLCFSM2025-12-18
10888857381551YUKON OCT Spinal SystemVB Spine LLCFSM2025-12-09
10888857291850MESA® Spinal SystemVB Spine LLCFSM2025-12-08
10888857446274MESA® Spinal SystemVB Spine LLCFSM2025-12-08