FDA.reportPublic FDA data

E.M Adams co, inc.

Primary DI
38100013402280
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
14-3407-1
Device description
SINGLE INSTRUMENT
Published
2019-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
38100013402280PackageGS120In Commercial Distribution
58100013402260PackageGS1100In Commercial Distribution
18100013402279PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3810001340228038100013402280
5810001340226058100013402260
1810001340227918100013402279

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, single-useA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues; it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
+1(772)461-0532EMADAMS@EMADAMSCO.COM

Regulatory Flags#

DUNS number
001403807
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
18100013402040E.M Adams co, inc.14-3358-12019-12-31
18100013402217E.M Adams co, inc.14-3392-12019-12-31
18100013402248E.M Adams co, inc.14-3393-12019-12-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327623260MakoMAKO SURGICAL CORP.FSM2026-05-29
08435389830207STOP & GUIDE® BOXBIOTECHNOLOGY INSTITUTE SLFSM2026-05-27
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