FDA.reportPublic FDA data

E.M Adams co, inc.

Primary DI
50840200301119
Brand
E.M Adams co, inc.
Company
E.M. ADAMS, INC.
Model
114-A1228-1
Device description
LACERATION PACK
Published
2021-05-22
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
50840200301119PackageGS120In Commercial Distribution
10840200301128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5084020030111950840200301119
1084020030112810840200301128

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
true
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
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
00810240701137G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701144G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
00810240701151G Surgical Marksman SystemG SURGICAL LLCFSM2026-11-05
07630055307743ROSA® Hip CT Instrument Tray - ShortIncipio Devices SAFSM2026-11-05
07630055307750ROSA® Hip CT Instrument Tray - TallIncipio Devices SAFSM2026-11-05
10889950159429Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-11-05
00889024713505G7® TM Acetabular SystemZimmer, Inc.FSM2026-11-03
05055662976694Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
05055662976717Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-11-03
08800322759509GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704070GSS™ and AnyPlus®GS Medical Co., Ltd.FSM2026-11-03
08800424704087Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
08800424704094Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.FSM2026-11-03
B382SD9233161140Surgical DirectSurgical Direct, Inc.FSM2026-11-03
00842078100196HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100202HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100226HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100233HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100240HammerFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100332IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078100349XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078101896Jones UnionEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078102770IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078103098IO FiX TrioEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078107935XMCPEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078108253APEXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109359IO FiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078109373CarpalFiXEXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110003CompressX2EXTREMITY MEDICAL, LLCFSM2026-11-02
00842078110102AlignXEXTREMITY MEDICAL, LLCFSM2026-11-02