FDA.reportPublic FDA data

E.M. Adams Co, Inc.

Primary DI
50840200325528
Brand
E.M. Adams Co, Inc.
Company
E.M. ADAMS, INC.
Model
14-3497-1
Device description
SINGLE INSTRUMENT
Published
2023-10-20
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
50840200325528PackageGS125In Commercial Distribution
10840200325537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5084020032552850840200325528
1084020032553710840200325537

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, alligator, single-useA long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures, typically during ear/nose/throat (ENT) surgery; it is not intended for insertion through an endoscope, nor into the eye and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. 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
false
No natural rubber latex
true
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
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
10840200301999E.M Adams co, inc.14-3350-12021-05-21

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Primary DI, Brand, Company table
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00196449035526Anatomic Access LLIFTyber Medical, LLCFSM2026-06-09
00889024701670Identity® Shoulder SystemZimmer, Inc.FSM2026-06-09
04251047924804Sterilizing CaseA1 Medical GmbHFSM2026-06-09
04251047926389Sterilization Tray with LidA1 Medical GmbHFSM2026-06-09
04251047930386Double-level Sterilization TrayA1 Medical GmbHFSM2026-06-09
00810055257874Surgical DesignSurgical Design, Inc.FSM2026-06-06
00810055257881Surgical DesignSurgical Design, Inc.FSM2026-06-06
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