FDA.report

APTUS

Primary DI
07630894803376
Brand
APTUS
Company
Medartis AG
Model
A-6502
Catalog number
A-6502
Device description
2/5 Case Effective Height 72mm
Published
2023-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07630037848820PreviousGS10
07630894803376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07630037848820076300378488207630037848820
07630894803376076308948033767630894803376

GMDN Terms

TermDefinition
Sterilization/disinfection container, reusableA receptacle designed to hold wrapped and/or unwrapped medical/dental devices in a chemical washer/disinfector and/or sterilizer during the washing/disinfection and/or sterilization cycle(s). It may be designed as a tray to allow full or partial immersion of the devices in a liquid disinfectant, or as an enclosed box to prevent contamination once the sterilization process is finished. The container may also be used for transport and storage of the processed devices, and may have features such as an expiry date label, breathing filter, built-in slots or inserts to hold instruments, and stacking capabilities. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
480054895
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
07630894829079APTUSA-2065A-20652026-01-09
07630894829062APTUSA-2056A-20562025-12-15
07630037863670APTUSA-4750.70/1SA-4750.70/1S2025-07-31
07630037865889APTUSA-3837SA-3837S2025-07-31
07630037883791APTUSA-5800.65/1SA-5800.65/1S2025-07-31
07630037883821APTUSA-5800.70/1SA-5800.70/1S2025-07-31
07630037883852APTUSA-5800.75/1SA-5800.75/1S2025-07-31
07630037883975APTUSA-5830.40/1SA-5830.40/1S2025-07-31
07630037883999APTUSA-5830.45/1SA-5830.45/1S2025-07-31
07630037884019APTUSA-5830.50/1SA-5830.50/1S2025-07-31
07630037884033APTUSA-5830.55/1SA-5830.55/1S2025-07-31
07630037884057APTUSA-5830.60/1SA-5830.60/1S2025-07-31
07630037884071APTUSA-5830.65/1SA-5830.65/1S2025-07-31
07630037884095APTUSA-5830.70/1SA-5830.70/1S2025-07-31
07630037884101APTUSA-5830.75/1SA-5830.75/1S2025-07-31
07630037884767APTUSA-5850.65/1SA-5850.65/1S2025-07-31
07630037884798APTUSA-5850.70/1SA-5850.70/1S2025-07-31
07630037884828APTUSA-5850.75/1SA-5850.75/1S2025-07-31
07630037897125APTUSA-4350.14TPA-4350.14TP2025-07-31
07630894811784APTUSA-4340.32TPA-4340.32TP2025-07-31

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850075235063TESA IF Screw SystemTesa Medical, Inc.FSM2026-05-26
00850075235070TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
00850075235179TESA Tensioner SystemTesa Medical, Inc.FSM2026-05-26
10889950157326Hu-FriedyHU-FRIEDY MFG. CO., LLCFSM2026-05-26
00888118150240PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150257PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150264PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150448IXOSKLS-Martin L.P.FSM2026-05-25
00888118150455IXOSKLS-Martin L.P.FSM2026-05-25
00888118150462IXOSKLS-Martin L.P.FSM2026-05-25
00888118150479IXOSKLS-Martin L.P.FSM2026-05-25
00888118150486IXOSKLS-Martin L.P.FSM2026-05-25
00888118150493IXOSKLS-Martin L.P.FSM2026-05-25
00888118153029L1 STERNALKLS-Martin L.P.FSM2026-05-25
00888118153050IXOSKLS-Martin L.P.FSM2026-05-25
00888118153067IXOSKLS-Martin L.P.FSM2026-05-25
00888118153074IXOSKLS-Martin L.P.FSM2026-05-25
00888118153081IXOSKLS-Martin L.P.FSM2026-05-25
00888118154613LEVEL ONEKLS-Martin L.P.FSM2026-05-25
07898663491562HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493108HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663493467HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495263HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495270HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663495751HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663496239HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663497267HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24