LDPE STIFFENER 24" X 18" X 1/16 "

GUDID 10841736112219

LDPE STIFFENER 24" X 18" X 1/16 "

SKYTRON LLC

Operating table patient pressure distribution pad, reusable
Primary Device ID10841736112219
NIH Device Record Keyf2852c97-1205-4526-ad99-3a503bd28b5c
Commercial Distribution Discontinuation2026-01-01
Commercial Distribution StatusIn Commercial Distribution
Brand NameLDPE STIFFENER 24" X 18" X 1/16 "
Version Model Number1-011-08-22-LP
Company DUNS078375583
Company NameSKYTRON LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us
Phone800-759-8766
Emailinfo@skytron.us

Operating and Storage Conditions

Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110841736112219 [Primary]

FDA Product Code

LWGSurgical Table Cushion

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2025-12-03
Device Publish Date2019-03-15

Devices Manufactured by SKYTRON LLC

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10841736124427 - Sterling 2025-12-17 P/M1000 MIS Rack with accessories
10841736124434 - Sterling 2025-12-17 P1800 MIS Rack with accessories
10841736124861 - Skytron2025-12-11 8 inch Clamp for P.T.E. (2 Pack)
10841736124878 - Skytron2025-12-11 2 inch STERIS 548 ARMBOARD PAD WS
10841736124885 - Skytron2025-12-11 3 inch STERIS 548 ARMBOARD PAD WS
10841736124892 - Skytron2025-12-11 4 inch STERIS 548 ARMBOARD PAD WS
10841736124908 - Skytron2025-12-11 5 inch STERIS 548 ARMBOARD PAD WS

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