FDA.reportPublic FDA data

ACTIV L

Primary DI
04046964999055
Brand
ACTIV L
Company
AESCULAP IMPLANT SYSTEMS, LLC
Model
ME248
Catalog number
ME248
Device description
ACTIVL S1 TRIAL CADDY
Published
2020-10-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964999055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964999055040469649990554046964999055

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)229-3002setworld_orders@aesculap.com
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
622600992
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046955171460AESCULAPME174RME174R2020-05-08
04038653399277SPECTRUMFG331TFG331T2017-01-20
04038653399284SPECTRUMFG333TFG333T2017-01-20
04038653399291SPECTRUMFG335TFG335T2017-01-20
04038653399307SPECTRUMFG337TFG337T2017-01-20
04038653399314SPECTRUMFG338TFG338T2017-01-20
04038653399321SPECTRUMFG339TFG339T2017-01-13
04038653399338SPECTRUMFG340TFG340T2017-01-13
04038653399345SPECTRUMFG341TFG341T2017-01-20
04038653399352SPECTRUMFG343TFG343T2017-01-20
04038653399369SPECTRUMFG345TFG345T2017-01-20
04038653399376SPECTRUMFG347TFG347T2017-01-20
04038653399383SPECTRUMFG349TFG349T2017-01-20
04038653399390SPECTRUMFG351TFG351T2017-01-20
04038653399406SPECTRUMFG353TFG353T2017-01-13
04038653399413SPECTRUMFG355TFG355T2017-01-20
04038653399420SPECTRUMFG356TFG356T2017-01-20
04038653399437SPECTRUMFG358TFG358T2017-01-20
04038653399444SPECTRUMFG359TFG359T2017-01-20
04038653399451SPECTRUMFG876TFG876T2017-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00888867504059Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504066Arthrex®ARTHREX, INC.FSM2026-09-21
00888867504073Arthrex®ARTHREX, INC.FSM2026-09-21
00749756400800DeRoyalDEROYAL INDUSTRIES, INC.FSM2026-09-18
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
10888857252820DENALI® Spinal SystemVB Spine LLCFSM2026-08-28
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
10888857596740NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596757NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596764NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596771NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596788NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596795NAPA Access SystemVB Spine LLCFSM2026-07-31
10888857596801NAPA Access SystemVB Spine LLCFSM2026-07-31