FDA.reportPublic FDA data

TOWEL SURGICAL E-STAR

Primary DI
00634916097726
Brand
TOWEL SURGICAL E-STAR
Company
STANDARD TEXTILE CO., INC.
Model
4888E513
Catalog number
4888E513
Device description
TOWEL SURG. E-STAR 2-KAUM'17X32 RM (98 8073) USE:48880413 AQUA
Published
2018-01-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRLFiber, Medical, Absorbent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRLFiber, Medical, AbsorbentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00634916097726PrimaryGS10
10634916097726Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00634916097726006349160977266349160977260634916097726
1063491609772610634916097726

GMDN Terms#

Term, Definition table
TermDefinition
Surgical towelA sterile cloth used in the operating room (OR) to absorb extraneous fluids. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-800-999-0400GUDID@standardtextile.com

Regulatory Flags#

DUNS number
006999858
Device count
288
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00634916019353Standard Supreme966893632026-03-11
00634916099225INSTRUMENT COVER965005122026-03-11
00634916120905Instrument Holder969007152026-03-11
00634916349740Compel MLR OR Gown7567B2162026-03-11
00634916781373WrapPel Table Cover969017842026-03-11
00634916788105Compel MLR OR Gown756747432026-03-11
00634916788112Compel MLR OR Gown756747442026-03-11
00634916788129Compel MLR OR Gown756747452026-03-11
00634916789249ProMax Surgical Gown756747652026-03-11
00634916789256ProMax Surgical Gown,756747642026-03-11
00634916789263ProMax Surgical Gown,756747632026-03-11
00634916792775OR Gown756748362026-03-11
00634916796322ComPel Surgical Gown756566G32026-03-11
00634916796339ComPel Surgical Gown756566G42026-03-11
00634916796346ComPel Surgical Gown756566G52026-03-11
00634916797114Reusable Gown 661YUAG42026-03-11
00634916797121Reusable Gown661YUAG52026-03-11
00634916797459ComPel Isolation Gown6610359V2026-03-11
00634916829358ProMax Surgical Gown756150762026-03-11
00634916870633Instrument Drape966008322026-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10814707025023CygnusASPEN SURGICAL PRODUCTS, INC.FRL2026-04-10
10850018327982MHMazza Healthcare LLCFRL2026-04-09
16931918102054HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918103969HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918107936HalyardGRI Medical & Electronic Technology Co., Ltd.FRL2025-11-11
16931918100913HALYARDGRI Medical & Electronic Technology Co., Ltd.FRL2025-09-17
10193489001907MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-08-06
10653160341628CenturionCENTURION MEDICAL PRODUCTS CORPORATIONFRL2025-07-06
10197106935132CARDINAL HEALTHCardinal Health 200, LLCFRL2025-02-24
10810178830135Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830142Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830159Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830166Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830173Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10810178830180Tally Surgical SolutionTally Surgical, Inc.FRL2025-02-20
10653160382928MEDLINEMEDLINE INDUSTRIES, INC.FRL2025-01-15
10193489009460REMEDYMEDLINE INDUSTRIES, INC.FRL2024-10-24
10193489012521MEDLINEMEDLINE INDUSTRIES, INC.FRL2024-10-24
10850049784402SURGYCOSurgyco LLCFRL2023-12-15
10850049784419SURGYCOSurgyco LLCFRL2023-12-15
10810132041843HCSConcordance Healthcare Solutions LLCFRL2023-10-16
10884389108949MedlineMEDLINE INDUSTRIES, INC.FRL2023-10-12
10850054813203Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813241Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813289Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-28
10850054813296Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813302Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813319Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-20
10850054813098Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12
10850054813104Airo™ CPAP Mask LinersAthfar 828 IncFRL2023-09-12