FDA.reportPublic FDA data

NA

Primary DI
04546540211316
Brand
NA
Company
Stryker Leibinger GmbH & Co. KG
Model
29-20500
Catalog number
29-20500
Device description
STERILIZING CONTAINER, UNIVERSAL
Published
2016-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
04546540211316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540211316045465402113164546540211316

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization containerA receptacle designed to hold wrapped and/or unwrapped surgical instruments (e.g. hand-held tools, surgical powered drills, hoses) during sterilization and for their subsequent storage. The container is permeable in order to allow moisture to escape from within after the sterilization process is finished, whilst protecting the contents from being contaminated. It may have features such as an expiry date label, sterile breathing filter, and stacking capabilities. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height95Millimeter
Length292Millimeter
Width283Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
316153956
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327682717NA92-0232592-023252026-02-27
07613327682724NA92-0232492-023242026-02-27
37613327090810NA92-1710592-171052015-09-24
37613327090827NA92-1710492-171042015-09-24
37613327090834NA92-1710692-171062015-09-24
37613327090841NA92-1710892-171082015-09-24
37613327090858NA92-8170392-817032015-09-24
37613327090865NA92-8170492-817042015-09-24
37613327090872NA92-8170592-817052015-09-24
37613327090889NA92-8170692-817062015-09-24
37613327090902NA92-8170892-817082015-09-24
37613327090919NA92-8171092-817102015-09-24
37613327090926NA92-8171292-817122015-09-24
37613327090940NA92-8190592-819052015-09-24
07613327579840N/A7000015775847000015775842025-09-08
07613327680522NA92-5553192-555312025-07-31
07613327651461NA92-0551292-055122025-07-09
07613327504385NA92-0233392-023332020-05-12
07613327504392NA92-0233292-023322020-05-12
07613327353563NA6002-140-2006002-140-2002025-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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07898663498080HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663498097HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24
07898663499292HANISCH MEDICALHanisch Medical LtdaFSM2026-03-24