FDA.reportPublic FDA data

LEOS

Primary DI
00196449001934
Brand
LEOS
Company
Tyber Medical LLC
Model
7624-1001
Catalog number
7624-1001
Device description
LEOS 02.7/3.5/4.0mm Screw Caddy
Published
2023-09-06
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

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
00196449001934PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449001934001964490019341964490019340196449001934

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933nmerlini@tybermed.com

Regulatory Flags#

DUNS number
010968002
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449024803Cannulated Headless Screw - Full Thread04.345.008TS2025-07-19
00196449024834Cannulated Headless Screw - Full Thread04.345.009TS2025-07-19
00196449024865Cannulated Headless Screw - Full Thread04.345.010TS2025-07-19
00196449024896Cannulated Headless Screw - Full Thread04.345.011TS2025-07-19
00196449024926Cannulated Headless Screw - Full Thread04.345.012TS2025-07-19
00196449024957Cannulated Headless Screw - Full Thread04.345.013TS2025-07-19
00196449024988Cannulated Headless Screw - Full Thread04.345.014TS2025-07-19
00196449025015Cannulated Headless Screw - Full Thread04.345.015TS2025-07-19
00196449025046Cannulated Headless Screw - Full Thread04.345.016TS2025-07-19
00196449025077Cannulated Headless Screw - Full Thread04.345.017TS2025-07-19
00196449025107Cannulated Headless Screw - Full Thread04.345.018TS2025-07-19
00196449025138Cannulated Headless Screw - Full Thread04.345.019TS2025-07-19
00196449025169Cannulated Headless Screw - Full Thread04.345.020TS2025-07-19
00196449025190Cannulated Headless Screw - Full Thread04.345.022TS2025-07-19
00196449025220Cannulated Headless Screw - Full Thread04.345.024TS2025-07-19
00196449025251Cannulated Headless Screw - Full Thread04.345.026TS2025-07-19
00196449025282Cannulated Headless Screw - Full Thread04.345.028TS2025-07-19
00196449025312Cannulated Headless Screw - Full Thread04.345.030TS2025-07-19
00196449025343Cannulated Headless Screw - Full Thread04.345.032TS2025-07-19
00196449025374Cannulated Headless Screw - Full Thread04.345.034TS2025-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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