FDA.reportPublic FDA data

SILICONE MAT

Primary DI
00888118086037
Brand
SILICONE MAT
Company
KLS-Martin L.P.
Model
55-348-01-01
Device description
FOR 55-348-00-01
Published
2020-06-19
Public version status
Update
Distribution status
Not 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
00888118086037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118086037008881180860378881180860370888118086037

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose bowl, reusableA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006974CURETTE01-500-01-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26
00888118023063STRIPPER16-251-30-012018-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024699939N/AZimmer, Inc.FSM2026-10-20
00889024699946N/AZimmer, Inc.FSM2026-10-20
00889024699953Alliance Glenoid, Identity HumeralZimmer, Inc.FSM2026-10-20
00810111228428Instrument TrayTreace Medical Concepts, Inc.FSM2026-10-16
00810161900909EARP IMPLANT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900916EARP INSTRUMENT TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900923EARP INSTRUMENT AND IMPLANT LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900930EARP RETRACTOR TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900947EARP RETRACTOR LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900954EARP, TRIAL CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900961EARP, TRIAL LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900978EARP, DISC SPACER CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161900985EARP, DISC SPACER LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901746EARP INSTRUMENT #2 TRAYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901753EARP INSTRUMENT #2 LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901814EARP, PLATFORM CADDYRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
00810161901821EARP, PLATFORM LIDRETROPSOAS TECHNOLOGIES, LLCFSM2026-10-16
04042409457203CHBSaap Implantate AGFSM2026-10-16
04042409457289CHBSaap Implantate AGFSM2026-10-16
04042409457302CHBSaap Implantate AGFSM2026-10-16
04042409457326CHBSaap Implantate AGFSM2026-10-16
04042409457340CHBSaap Implantate AGFSM2026-10-16
05055662966855Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-10-16
05055662966862Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDFSM2026-10-16
00724995239992V. MuellerSteris CorporationFSM2026-10-15
00724995240004V. MuellerSteris CorporationFSM2026-10-15
00724995240011V. MuellerSteris CorporationFSM2026-10-15
00724995240028V. MuellerSteris CorporationFSM2026-10-15
00724995243401V. MuellerSteris CorporationFSM2026-10-15
00889795150271APEX 3D Total Ankle Replacement SystemParagon 28, Inc.FSM2026-10-12